Formyco

Formyco may be available in the countries listed below.

Ingredient matches for Formyco

Ketoconazole

Ketoconazole is reported as an ingredient of Formyco in the following countries:

• Indonesia

International Drug Name Search

Alfuzosine Uno Winthrop

Alfuzosine Uno Winthrop may be available in the countries listed below.

Ingredient matches for Alfuzosine Uno Winthrop

Alfuzosin

Alfuzosin hydrochloride (a derivative of Alfuzosin) is reported as an ingredient of Alfuzosine Uno Winthrop in the following countries:

• Switzerland

International Drug Name Search

Mephanol

Mephanol may be available in the countries listed below.

Ingredient matches for Mephanol

Allopurinol

Allopurinol is reported as an ingredient of Mephanol in the following countries:

• Switzerland

International Drug Name Search

Pigenil

Pigenil may be available in the countries listed below.

Ingredient matches for Pigenil

Docosanol

Docosanol is reported as an ingredient of Pigenil in the following countries:

• Italy

International Drug Name Search

Extur

Extur may be available in the countries listed below.

Ingredient matches for Extur

Indapamide

Indapamide is reported as an ingredient of Extur in the following countries:

• Spain

International Drug Name Search

Epsoclar

Epsoclar may be available in the countries listed below.

Ingredient matches for Epsoclar

Heparin

Heparin sodium salt (a derivative of Heparin) is reported as an ingredient of Epsoclar in the following countries:

• Italy

International Drug Name Search

Purinéthol

Purinéthol may be available in the countries listed below.

Ingredient matches for Purinéthol

Mercaptopurine

Mercaptopurine monohydrate (a derivative of Mercaptopurine) is reported as an ingredient of Purinéthol in the following countries:

• France

International Drug Name Search

Lorazepan Chobet

Lorazepan Chobet may be available in the countries listed below.

Ingredient matches for Lorazepan Chobet

Lorazepam

Lorazepam is reported as an ingredient of Lorazepan Chobet in the following countries:

• Argentina

International Drug Name Search

Gentacort

Gentacort may be available in the countries listed below.

Ingredient matches for Gentacort

Fluorometholone

Fluorometholone is reported as an ingredient of Gentacort in the following countries:

• Italy

Gentamicin

Gentamicin sulfate (a derivative of Gentamicin) is reported as an ingredient of Gentacort in the following countries:

• Italy

International Drug Name Search

Asmalin

Asmalin may be available in the countries listed below.

Ingredient matches for Asmalin

Salbutamol

Salbutamol sulfate (a derivative of Salbutamol) is reported as an ingredient of Asmalin in the following countries:

• Philippines

International Drug Name Search

Bromazépam

Bromazépam may be available in the countries listed below.

Ingredient matches for Bromazépam

Bromazepam

Bromazépam (DCF) is also known as Bromazepam (Rec.INN)

International Drug Name Search

Glossary

DCF	Dénomination Commune Française
Rec.INN	Recommended International Nonproprietary Name (World Health Organization)

Click for further information on drug naming conventions and International Nonproprietary Names.

Fosamac

Fosamac may be available in the countries listed below.

Ingredient matches for Fosamac

Alendronic Acid

Alendronic Acid sodium trihydrate (a derivative of Alendronic Acid) is reported as an ingredient of Fosamac in the following countries:

• Japan

International Drug Name Search

Alendroninezuur Ratiopharm

Alendroninezuur Ratiopharm may be available in the countries listed below.

Ingredient matches for Alendroninezuur Ratiopharm

Alendronic Acid

Alendronic Acid sodium trihydrate (a derivative of Alendronic Acid) is reported as an ingredient of Alendroninezuur Ratiopharm in the following countries:

• Netherlands

International Drug Name Search

Cyclopentolate Minims

Cyclopentolate Minims may be available in the countries listed below.

Ingredient matches for Cyclopentolate Minims

Cyclopentolate

Cyclopentolate hydrochloride (a derivative of Cyclopentolate) is reported as an ingredient of Cyclopentolate Minims in the following countries:

• Belgium


• Norway

International Drug Name Search

Mucosolate

Mucosolate may be available in the countries listed below.

Ingredient matches for Mucosolate

Ambroxol

Ambroxol hydrochloride (a derivative of Ambroxol) is reported as an ingredient of Mucosolate in the following countries:

• Japan

International Drug Name Search

Bromocalcio

Bromocalcio may be available in the countries listed below.

Ingredient matches for Bromocalcio

Calcium Bromolactobionate

Calcium Bromolactobionate is reported as an ingredient of Bromocalcio in the following countries:

• Chile

International Drug Name Search

Fabrazol

Fabrazol may be available in the countries listed below.

Ingredient matches for Fabrazol

Omeprazole

Omeprazole is reported as an ingredient of Fabrazol in the following countries:

• Argentina

International Drug Name Search

Thiopental Valeant

Thiopental Valeant may be available in the countries listed below.

Ingredient matches for Thiopental Valeant

Thiopental

Thiopental Sodium is reported as an ingredient of Thiopental Valeant in the following countries:

• Czech Republic


• Slovakia

International Drug Name Search

Foristal

Foristal may be available in the countries listed below.

Ingredient matches for Foristal

Dimetindene

Dimetindene maleate (a derivative of Dimetindene) is reported as an ingredient of Foristal in the following countries:

• India

International Drug Name Search

Bisoprolol RPG

Bisoprolol RPG may be available in the countries listed below.

Ingredient matches for Bisoprolol RPG

Bisoprolol

Bisoprolol fumarate (a derivative of Bisoprolol) is reported as an ingredient of Bisoprolol RPG in the following countries:

• France

International Drug Name Search

Mithra-Alprazolam

Mithra-Alprazolam may be available in the countries listed below.

Ingredient matches for Mithra-Alprazolam

Alprazolam

Alprazolam is reported as an ingredient of Mithra-Alprazolam in the following countries:

• Luxembourg

International Drug Name Search

Moclobemid AL

Moclobemid AL may be available in the countries listed below.

Ingredient matches for Moclobemid AL

Moclobemide

Moclobemide is reported as an ingredient of Moclobemid AL in the following countries:

• Germany

International Drug Name Search

Iodine Midwest

Iodine Midwest may be available in the countries listed below.

Ingredient matches for Iodine Midwest

Povidone Iodine

Povidone-Iodine is reported as an ingredient of Iodine Midwest in the following countries:

• New Zealand

International Drug Name Search

Claritromicina Ranbaxy

Claritromicina Ranbaxy may be available in the countries listed below.

Ingredient matches for Claritromicina Ranbaxy

Clarithromycin

Clarithromycin is reported as an ingredient of Claritromicina Ranbaxy in the following countries:

• Italy


• Portugal


• Spain

International Drug Name Search

Bretam

Bretam may be available in the countries listed below.

Ingredient matches for Bretam

Piracetam

Piracetam is reported as an ingredient of Bretam in the following countries:

• Vietnam

International Drug Name Search

Enalapril Domesco

Enalapril Domesco may be available in the countries listed below.

Ingredient matches for Enalapril Domesco

Enalapril

Enalapril is reported as an ingredient of Enalapril Domesco in the following countries:

• Vietnam

International Drug Name Search

Cloxagel

Cloxagel may be available in the countries listed below.

In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for Cloxagel

Cloxacillin

Cloxacillin benzathine (a derivative of Cloxacillin) is reported as an ingredient of Cloxagel in the following countries:

• France

Cloxacillin benzathine and sodium (a derivative of Cloxacillin) is reported as an ingredient of Cloxagel in the following countries:

• New Zealand

Cloxacillin sodium salt (a derivative of Cloxacillin) is reported as an ingredient of Cloxagel in the following countries:

• Austria


• New Zealand

Neomycin

Neomycin sulfate (a derivative of Neomycin) is reported as an ingredient of Cloxagel in the following countries:

• Austria


• France


• New Zealand

International Drug Name Search

Antopar

Antopar may be available in the countries listed below.

Ingredient matches for Antopar

Benzoyl Peroxide

Benzoyl Peroxide is reported as an ingredient of Antopar in the following countries:

• Slovenia

International Drug Name Search

Rodenal

Rodenal may be available in the countries listed below.

Ingredient matches for Rodenal

Trihexyphenidyl

Trihexyphenidyl hydrochloride (a derivative of Trihexyphenidyl) is reported as an ingredient of Rodenal in the following countries:

• Israel

International Drug Name Search

Pascalium

Pascalium may be available in the countries listed below.

Ingredient matches for Pascalium

Bromazepam

Bromazepam is reported as an ingredient of Pascalium in the following countries:

• Greece

International Drug Name Search

Anusol Plus

Anusol Plus may be available in the countries listed below.

Ingredient matches for Anusol Plus

Pramocaine

Pramocaine hydrochloride (a derivative of Pramocaine) is reported as an ingredient of Anusol Plus in the following countries:

• Canada

Zinc Sulfate

Zinc Sulfate is reported as an ingredient of Anusol Plus in the following countries:

• Canada

International Drug Name Search

Beconase

UK matches:

• Beconase Aqueous Nasal Spray
• Beconase Aqueous Nasal Spray (SPC)
• Beconase Hayfever (SPC)
• Beconase Hayfever Relief for Adults 0.05% Nasal Spray (SPC)

Ingredient matches for Beconase

Beclometasone

Beclometasone 17α,21-dipropionate (a derivative of Beclometasone) is reported as an ingredient of Beconase in the following countries:

• Antigua & Barbuda


• Aruba


• Australia


• Bahamas


• Bahrain


• Bangladesh


• Barbados


• Belgium


• Bermuda


• Chile


• Colombia


• Costa Rica


• Czech Republic


• Denmark


• Dominican Republic


• El Salvador


• Estonia


• Ethiopia


• Finland


• Georgia


• Germany


• Grenada


• Guatemala


• Guyana


• Honduras


• Hong Kong


• Iceland


• Iran


• Ireland


• Israel


• Jamaica


• Kuwait


• Latvia


• Lithuania


• Malta


• Mexico


• Netherlands Antilles


• New Zealand


• Nicaragua


• Oman


• Panama


• Peru


• Poland


• Portugal


• Qatar


• Romania


• Saint Lucia


• Serbia


• South Africa


• Switzerland


• Trinidad & Tobago


• United Arab Emirates


• United Kingdom


• United States


• Venezuela

Betamethasone

Betamethasone 17α,21-dipropionate (a derivative of Betamethasone) is reported as an ingredient of Beconase in the following countries:

• Cayman Islands

International Drug Name Search

Glossary

SPC	Summary of Product Characteristics (UK)

Click for further information on drug naming conventions and International Nonproprietary Names.

Photofrin

In the US, Photofrin (porfimer systemic) is a member of the drug class miscellaneous antineoplastics and is used to treat Esophageal Carcinoma and Non-Small Cell Lung Cancer.

US matches:

• Photofrin

Ingredient matches for Photofrin

Porfimer

Porfimer Sodium is reported as an ingredient of Photofrin in the following countries:

• Canada


• Chile


• Germany


• Hungary


• Israel


• Japan


• Poland


• Taiwan


• United States

International Drug Name Search

Codifarma

Codifarma may be available in the countries listed below.

Ingredient matches for Codifarma

Codeine

Codeine is reported as an ingredient of Codifarma in the following countries:

• Peru

International Drug Name Search

Ramipril comp.-CT

Ramipril comp.-CT may be available in the countries listed below.

Ingredient matches for Ramipril comp.-CT

Hydrochlorothiazide

Hydrochlorothiazide is reported as an ingredient of Ramipril comp.-CT in the following countries:

• Germany

Ramipril

Ramipril is reported as an ingredient of Ramipril comp.-CT in the following countries:

• Germany

International Drug Name Search

Cinaryl

Cinaryl may be available in the countries listed below.

Ingredient matches for Cinaryl

Cinnarizine

Cinnarizine is reported as an ingredient of Cinaryl in the following countries:

• Bangladesh

International Drug Name Search

Clanobutin

In some countries, this medicine may only be approved for veterinary use.

Scheme

Rec.INN

CAS registry number (Chemical Abstracts Service)

0030544-61-7

Chemical Formula

C18-H18-Cl-N-O4

Molecular Weight

347

Therapeutic Category

Choleretic

Chemical Name

Butanoic acid, 4-[(4-chlorobenzoyl)(4-methoxyphenyl)amino]-

Foreign Names

• Clanobutinum (Latin)
• Clanobutin (German)
• Clanobutine (French)
• Clanobutina (Spanish)

Generic Name

• B 6518 (IS: Byk Gulden)

Brand Names

• Bykahépar (veterinary use)
  Intervet, France



• Clanohepar (veterinary use)
  Biowet Pulawy, Poland



• Bykahépar (veterinary use)
  Intervet, France

International Drug Name Search

Glossary

IS	Inofficial Synonym
Rec.INN	Recommended International Nonproprietary Name (World Health Organization)

Click for further information on drug naming conventions and International Nonproprietary Names.

Meliane

Meliane may be available in the countries listed below.

Ingredient matches for Meliane

Ethinylestradiol

Ethinylestradiol is reported as an ingredient of Meliane in the following countries:

• Austria


• Belgium


• Colombia


• Greece


• Hungary


• Luxembourg


• Malta


• Spain


• Switzerland


• Thailand

Gestodene

Gestodene is reported as an ingredient of Meliane in the following countries:

• Austria


• Belgium


• Colombia


• Greece


• Hungary


• Luxembourg


• Malta


• Spain


• Switzerland


• Thailand

International Drug Name Search

Frusedale

Frusedale may be available in the countries listed below.

In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for Frusedale

Furosemide

Furosemide is reported as an ingredient of Frusedale in the following countries:

• United Kingdom

International Drug Name Search

Avyplus

Avyplus may be available in the countries listed below.

Ingredient matches for Avyplus

Acyclovir

Aciclovir is reported as an ingredient of Avyplus in the following countries:

• Italy

International Drug Name Search

Futhan

Futhan may be available in the countries listed below.

Ingredient matches for Futhan

Nafamostat

Nafamostat mesilate (a derivative of Nafamostat) is reported as an ingredient of Futhan in the following countries:

• Japan

International Drug Name Search

Raynanon

Raynanon may be available in the countries listed below.

Ingredient matches for Raynanon

Ketoprofen

Ketoprofen is reported as an ingredient of Raynanon in the following countries:

• Japan

International Drug Name Search

Lanicor

Lanicor may be available in the countries listed below.

Ingredient matches for Lanicor

Digoxin

Digoxin is reported as an ingredient of Lanicor in the following countries:

• Argentina


• Botswana


• Croatia (Hrvatska)


• Czech Republic


• Ecuador


• Germany


• Ghana


• Kenya


• Luxembourg


• Malawi


• Namibia


• Nigeria


• Sudan


• Tanzania


• Uganda


• Venezuela


• Zambia


• Zimbabwe

International Drug Name Search

Bromazepam beta

Bromazepam beta may be available in the countries listed below.

Ingredient matches for Bromazepam beta

Bromazepam

Bromazepam is reported as an ingredient of Bromazepam beta in the following countries:

• Germany

International Drug Name Search

Bicalutamid Nycomed

Bicalutamid Nycomed may be available in the countries listed below.

Ingredient matches for Bicalutamid Nycomed

Bicalutamide

Bicalutamide is reported as an ingredient of Bicalutamid Nycomed in the following countries:

• Switzerland

International Drug Name Search

Folsan

Folsan may be available in the countries listed below.

Ingredient matches for Folsan

Folic Acid

Folic Acid is reported as an ingredient of Folsan in the following countries:

• Austria


• Germany

International Drug Name Search

Finasterida Stada

Finasterida Stada may be available in the countries listed below.

Ingredient matches for Finasterida Stada

Finasteride

Finasteride is reported as an ingredient of Finasterida Stada in the following countries:

• Spain

International Drug Name Search

Microgynon 30 Combiphar

Microgynon 30 Combiphar may be available in the countries listed below.

Ingredient matches for Microgynon 30 Combiphar

Ethinylestradiol

Ethinylestradiol is reported as an ingredient of Microgynon 30 Combiphar in the following countries:

• Netherlands

Levonorgestrel

Levonorgestrel is reported as an ingredient of Microgynon 30 Combiphar in the following countries:

• Netherlands

International Drug Name Search

Epsicaprom

Epsicaprom may be available in the countries listed below.

Ingredient matches for Epsicaprom

Aminocaproic Acid

Aminocaproic Acid is reported as an ingredient of Epsicaprom in the following countries:

• Portugal

International Drug Name Search

Phenxycap

Phenxycap may be available in the countries listed below.

Ingredient matches for Phenxycap

Glucosamine

Glucosamine sulfate (a derivative of Glucosamine) is reported as an ingredient of Phenxycap in the following countries:

• Vietnam

International Drug Name Search

Pyrethia

Pyrethia may be available in the countries listed below.

Ingredient matches for Pyrethia

Promethazine

Promethazine hydrochloride (a derivative of Promethazine) is reported as an ingredient of Pyrethia in the following countries:

• Japan

International Drug Name Search

Manidip

Manidip may be available in the countries listed below.

Ingredient matches for Manidip

Manidipine

Manidipine dihydrochloride (a derivative of Manidipine) is reported as an ingredient of Manidip in the following countries:

• Japan

International Drug Name Search

Chloramphenicol Valeant

Chloramphenicol Valeant may be available in the countries listed below.

Ingredient matches for Chloramphenicol Valeant

Chloramphenicol

Chloramphenicol succinate sodium (a derivative of Chloramphenicol) is reported as an ingredient of Chloramphenicol Valeant in the following countries:

• Czech Republic


• Slovakia

International Drug Name Search

Mercaptopurine monohydrate

Mercaptopurine monohydrate may be available in the countries listed below.

Ingredient matches for Mercaptopurine monohydrate

Mercaptopurine

Mercaptopurine monohydrate (BAN) is known as Mercaptopurine in the US.

International Drug Name Search

Glossary

BAN	British Approved Name

Click for further information on drug naming conventions and International Nonproprietary Names.

Rizan

Rizan may be available in the countries listed below.

Ingredient matches for Rizan

Pimecrolimus

Pimecrolimus is reported as an ingredient of Rizan in the following countries:

• Spain

International Drug Name Search

Cinnarizin Domesco

Cinnarizin Domesco may be available in the countries listed below.

Ingredient matches for Cinnarizin Domesco

Cinnarizine

Cinnarizine is reported as an ingredient of Cinnarizin Domesco in the following countries:

• Vietnam

International Drug Name Search

Fluconazol Markos

Fluconazol Markos may be available in the countries listed below.

Ingredient matches for Fluconazol Markos

Fluconazole

Fluconazole is reported as an ingredient of Fluconazol Markos in the following countries:

• Peru

International Drug Name Search

Locacorten-Vioform

Locacorten-Vioform may be available in the countries listed below.

Ingredient matches for Locacorten-Vioform

Clioquinol

Clioquinol is reported as an ingredient of Locacorten-Vioform in the following countries:

• Australia


• Canada


• Denmark


• Germany


• Netherlands


• Sweden

Flumetasone

Flumetasone 21-pivalate (a derivative of Flumetasone) is reported as an ingredient of Locacorten-Vioform in the following countries:

• Australia


• Canada


• Denmark


• Germany


• Netherlands


• Sweden

International Drug Name Search

Pur-Bloka

Pur-Bloka may be available in the countries listed below.

Ingredient matches for Pur-Bloka

Propranolol

Propranolol hydrochloride (a derivative of Propranolol) is reported as an ingredient of Pur-Bloka in the following countries:

• South Africa

International Drug Name Search

Cholinfall

Cholinfall may be available in the countries listed below.

Ingredient matches for Cholinfall

Metixene

Metixene hydrochloride (a derivative of Metixene) is reported as an ingredient of Cholinfall in the following countries:

• Japan

International Drug Name Search

Eqvalan

In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for Eqvalan

Ivermectin

Ivermectin is reported as an ingredient of Eqvalan in the following countries:

• Australia


• Austria


• Belgium


• France


• Germany


• Ireland


• Italy


• Luxembourg


• Netherlands


• New Zealand


• Poland


• Portugal


• South Africa


• Switzerland


• United Kingdom


• United States

Praziquantel

Praziquantel is reported as an ingredient of Eqvalan in the following countries:

• Australia


• Austria


• France


• Germany


• Luxembourg


• New Zealand


• Poland


• South Africa


• Switzerland

International Drug Name Search

HI-Floxin

HI-Floxin may be available in the countries listed below.

Ingredient matches for HI-Floxin

Ciprofloxacin

Ciprofloxacin hydrochloride (a derivative of Ciprofloxacin) is reported as an ingredient of HI-Floxin in the following countries:

• Bangladesh

International Drug Name Search

Regaine for Men Extra Strength Scalp Foam 5% w / w Cutaneous Foam

1. Name Of The Medicinal Product

Regaine for Men Extra Strength Scalp Foam 5% w/w Cutaneous Foam

2. Qualitative And Quantitative Composition

Minoxidil 50 mg/g (5% w/w)

Contains butylhydroxytoluene (BHT), stearyl alcohol and cetyl alcohol.

For full list of excipients, see section 6.1.

3. Pharmaceutical Form

Cutaneous foam

White to off-white foam

4. Clinical Particulars

4.1 Therapeutic Indications

Regaine for Men Extra Strength Scalp Foam 5% w/w Cutaneous Foam is indicated for the treatment of alopecia androgenetica in men.

4.2 Posology And Method Of Administration

Men aged 18-49:

Hair and scalp should be thoroughly dry prior to topical application of Regaine for Men Extra Strength Scalp Foam 5% w/w Cutaneous Foam. A dose of 1 g (equivalent to the volume of half a capful) Regaine for Men Extra Strength Scalp Foam 5% w/w Cutaneous Foam should be applied to the total affected areas of the scalp twice daily. The total daily dosage should not exceed 2 g.

Hold can upside down and press nozzle to dispense foam onto the hand. Spread with fingertips over entire bald area. Hands should be washed thoroughly after application.

It may take twice-daily applications for 8 weeks or more before evidence of hair growth can be expected. Users should discontinue treatment if there is no improvement seen after 16 weeks.

If hair regrowth occurs, twice daily applications of Regaine for Men Extra Strength Scalp Foam 5% w/w Cutaneous Foam are necessary for continued hair growth.

Clinical Trials have not investigated the efficacy of Regaine for Men Extra Strength Scalp Foam 5% w/w Cutaneous Foam beyond 16 weeks.

Children and men over 49 years

Not recommended. The safety and effectiveness of Regaine for Men Extra Strength Scalp Foam 5% w/w Cutaneous Foam in users aged under 18 or over 49 has not been established.

4.3 Contraindications

Regaine for Men Extra Strength Scalp Foam 5% w/w Cutaneous Foam is contraindicated:

− in women

− in users with a history of sensitivity to Minoxidil or any of the other ingredients

− in users with treated or untreated hypertension

− in users with any scalp abnormality (including psoriasis and sunburn)

− in users with a shaved scalp

− if occlusive dressings or other topical medical preparations are being used.

4.4 Special Warnings And Precautions For Use

Before using Regaine for Men Extra Strength Scalp Foam 5% w/w Cutaneous Foam, the user should determine that the scalp is normal and healthy.

Minoxidil is not indicated when there is no family history of hair loss, hair loss is sudden and/or patchy, hair loss is due to childbirth, or the reason for hair loss is unknown.

The patient should stop using Regaine for Men Extra Strength Scalp Foam 5% w/w Cutaneous Foam and see a doctor if hypotension is detected or if the patient is experiencing chest pain, rapid heartbeat, faintness or dizziness, sudden unexplained weight gain, swollen hands or feet or persistent redness.

Patients with known cardiovascular disease or cardiac arrhythmia should contact a physician before using Regaine for Men Extra Strength Scalp Foam 5% w/w Cutaneous Foam.

Regaine for Men Extra Strength Scalp Foam 5% w/w Cutaneous Foam is for external use only. Do not apply to areas of the body other than the scalp.

Hands should be washed thoroughly after applying the foam.

Regaine for Men Extra Strength Scalp Foam 5% w/w Cutaneous Foam contains ethanol (alcohol), which will cause burning and irritation of the eye. In the event of accidental contact with sensitive surfaces (eye, abraded skin and mucous membranes) the area should be bathed with large amounts of cool tap water.

Regaine for Men Extra Strength Scalp Foam 5% w/w Cutaneous Foam also contains butylated hydroxytoluene, which may cause local skin reactions (e.g. contact dermatitis), or irritation to the eyes or mucous membranes, and cetyl and stearyl alcohol, which may cause local skin reactions (e.g. contact dermatitis)

Some patients have experienced changes in hair colour and/or texture with Regaine for Men Extra Strength Scalp Foam 5% w/w Cutaneous Foam use.

Some consumers reported increased hair shedding upon initiation of therapy with Regaine for Men Extra Strength Scalp Foam 5% w/w Cutaneous Foam. This is most likely due to minoxidil's action of shifting hairs from the resting telogen phase to the growing anagen phase (old hairs fall out as new hairs grow in their place). This temporary increase in hair shedding generally occurs two to six weeks after beginning treatment and subsides within a couple of weeks. If shedding persists (> 2 weeks), users should stop using Regaine for Men Extra Strength Scalp Foam 5% w/w Cutaneous Foam and consult their doctor.

Users should be aware that, whilst extensive use of Regaine for Men Extra Strength Scalp Foam 5% w/w Cutaneous Foam has not revealed evidence that sufficient minoxidil is absorbed to have systemic effects, greater absorption because of misuse, individual variability, unusual sensitivity or decreased integrity of the epidermal barrier caused by inflammation or disease processes in the skin (eg. excoriations of the scalp, or scalp psoriasis) could lead, at least theoretically, to systemic effects.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Topical drugs, such as tretinoin or dithranol, which alter the stratum corneum barrier, could result in increased absorption of minoxidil if applied concurrently. Although it has not been demonstrated clinically, there exists the theoretical possibility of absorbed minoxidil potentiating orthostatic hypotension caused by peripheral vasodilators.

Betamethasone diproprionate increases local tissue concentrations of minoxidil and decreases systemic minoxidil absorption.

4.6 Pregnancy And Lactation

Systemically absorbed minoxidil is secreted in human milk.

There are no adequate and well-controlled studies in pregnant women.

Animal studies have shown a risk to the foetus at exposure levels that are very high compared to those intended for human exposure. A low, albeit remote, risk of foetal harm is possible in humans.

Regaine for Men Extra Strength Scalp Foam 5% w/w Cutaneous Foam should not be used during pregnancy or lactation.

4.7 Effects On Ability To Drive And Use Machines

Based on the pharmacodynamic and overall safety profile of minoxidil, it is not expected that Regaine for Men Extra Strength Scalp Foam 5% w/w Cutaneous Foam would interfere with the ability to drive or operate machinery.

4.8 Undesirable Effects

For the assessment of undesirable effects the following frequencies apply:

Very common (

The following adverse events were associated with the use of minoxidil solution (2% and 5% combined) in males and females, at an incidence greater than 1 %, and greater than placebo in seven placebo-controlled clinical trials.

Very Common:

Neurological: headache

Common:

Respiratory: dyspnoea

Dermatological: pruritus, hypertrichosis, acneform rash, dermatitis, inflammatory skin disorder

Musculoskeletal: musculoskeletal pain

Metabolic/Nutritional: peripheral oedema

Psychiatric: depression

Miscellaneous: pain

Clinical Trial with Minoxidil Foam

The following adverse events were associated with the use of 5% minoxidil foam in males, at an incidence greater than 1 %, and greater than placebo in one placebo-controlled clinical trial.

Common: Body as a Whole: headache

Skin: pruritus, rash

Cardiovascular: hypertension

Post Marketing Experience - Minoxidil Solution

The following additional adverse events which have been observed with the application of topical minoxidil solutions during post-marketing use might also be relevant for topical minoxidil foam: irritation at the application site, dry skin, skin exfoliation, temporary hair loss, application site erythema, contact dermatitis or hypotension.

Users should stop using Regaine for Men Extra Strength Scalp Foam 5% w/w Cutaneous Foam if they experience chest-pain, tachycardia, faintness, dizziness, sudden unexplained weight gain, swollen hands or feet or persistent redness or irritation of the scalp.

4.9 Overdose

Increased systemic absorption of minoxidil may potentially occur if higher-than-recommended doses of Regaine for Men Extra Strength Scalp Foam 5% w/w Cutaneous Foam are applied to larger surface areas of the body or areas other than the scalp.

Because of the concentration of minoxidil in Regaine for Men Extra Strength Scalp Foam 5% w/w Cutaneous Foam, accidental ingestion has the potential of producing systemic effects related to the pharmacological action of the drug (2 g of Regaine for Men Extra Strength Scalp Foam 5% w/w Cutaneous Foam contains 100 mg minoxidil; the maximum recommended adult dose for oral minoxidil administration in the treatment of hypertension). Signs and symptoms of minoxidil overdosage would primarily be cardiovascular effects associated with sodium and water retention, and tachycardia, hypotension and dizziness can also occur. Fluid retention can be managed with appropriate diuretic therapy. Clinically significant tachycardia can be controlled by administration of a beta-adrenergic blocking agent.

Treatment

Treatment of minoxidil overdosage should be symptomatic and supportive.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Other dermatologicals, ATC code: D11AX.

Minoxidil stimulates hair growth in persons with early and moderate stages of hereditary hair loss (alopecia androgenetica). This hair loss appears in men as a receding hairline and balding in the vertex area. The exact mechanism of action of minoxidil for topical treatment of alopecia is not fully understood, but minoxidil can reverse the hair loss process of androgenetic alopecia by the following means:

− increasing the diameter of the hair shaft

− stimulating anagen growth

− prolonging the anagen phase

− stimulating anagen recovery from the telegen phase

As a peripheral vasodilator minoxidil enhances microcirculation to hair follicles. The Vascular Endothelial Growth Factor (VEGF) is stimulated by minoxidil and VEGF is presumably responsible for the increased capillary fenestration, indicative of a high metabolic activity, observed during the anagen phase.

The efficacy of 5% minoxidil foam has been assessed in a Phase 3 clinical trial conducted over a 16-week treatment period. In this study 5% minoxidil foam was compared to the product vehicle without the minoxidil active ingredient.

The primary efficacy endpoints were a) mean change in non-vellus hair count within the target region between Baseline and Week 16, as determined by validated computer-assisted dot-mapping technique; and b) subject rating of treatment benefit via use of global photographs of the vertex region, assessed as an overall improvement from baseline, collected on a subject questionnaire.

The active treatment showed a statistically significant greater increase in hair count than the vehicle foam group (21.0 versus 4.3 hairs cm²) at week 16. A clear difference between treatment groups was already evident at week 8, increasing at week 12 and again at week 16. The subject`s rating of treatment benefit was statistically significantly better for the 5% minoxidil foam treatment group than placebo (1.4 vs 0.5) at week 16.

The secondary efficacy endpoints were a) expert panel review (EPR) of hair regrowth when comparing global photographs obtained at baseline with photographs obtained at Week 16 and b) percent change from baseline in non-vellus hair counts within a pre-specified area of clipped hair.

The 5% minoxidil foam group showed a better score in the expert panel review (EPR) than the placebo foam group (adjusted mean 0.5 vs 0.1, p<0.0001).

At weeks 8, 12 and 16, the difference in adjusted means for percent change in non-vellus hair counts between vehicle foam and minoxidil foam were statistically significant (p<0.0001 at all 3 visits).

Regaine Foam Data: Mean change in non-vellus hair count in reference 1cm² area of scalp compared with baseline

	Regaine for Men Extra Strength Foam (n=180)	Placebo (n=172)	Difference (p-value)
Baseline haircount	170.8	168.9
	Mean change from baseline	Mean change from baseline
8 weeks	16.0	4.9	11.1 (<0.0001)
12 weeks	19.9	4.5	15.4 (<0.0001)
16 weeks	21.0	4.3	16.7 (<0.0001)

5.2 Pharmacokinetic Properties

The failure to detect evidence of systemic effects during treatment with Regaine Foam reflects the poor absorption of topically applied minoxidil from normal intact skin. Systemic absorption of minoxidil from topically applied solution ranges between 1% and 2% of the total applied dose.

The systemic absorption of minoxidil from a 5% foam formulation has been estimated in a pharmacokinetic study in subjects with androgenetic alopecia, which included 5% topical solution as a comparator. This demonstrated that in men, the systemic absorption of minoxidil from twice daily application of 5% minoxidil foam was about half of that observed with 5% minoxidil solution. The mean steady state AUC (0-12 hr) and Cmax for 5% minoxidil foam, 8.81 ng·hr/mL and 1.11 ng/mL, respectively, were both approximately 50 % of AUC (0-12 hr) and Cmax of the 5% solution, 18.71 ng·hr/mL and 2.13 ng/mL, respectively. The time to maximum minoxidil concentration (Tmax) for the 5% foam, 5.42 hr, was similar to Tmax for the 5% solution, 5.79 hr.

There is some evidence from in vitro studies that minoxidil reversibly binds to human plasma proteins. However, since only 1 – 2% of topically applied minoxidil is absorbed, the extent of plasma protein binding occurring in vivo after topical application would be clinically insignificant. The volume of distribution of minoxidil after intravenous administration has been estimated at 70 litres.

Approximately 60% minoxidil absorbed after topical application is metabolised to minoxidil glucuronide, primarily in the liver. Minoxidil and its metabolites are excreted almost entirely in the urine, with a very minor degree of elimination via the faeces. Following cessation of dosing, approximately 95% of topically applied minoxidil will be eliminated within four days.

5.3 Preclinical Safety Data

Mutagenicity

Minoxidil showed no evidence of mutagenic/genotoxic potential in a number of in vitro and in vivo assays.

Carcinogenicity

A high incidence of hormone-mediated tumours was observed in mice and rats. These tumours are due to the secondary hormonal (hyperprolactinemia) effects observed only in the rodents at extremely high doses by a mechanism similar to that seem with reserpine. Application of topical minoxidil has not demonstrated any effect on hormonal status in women. Therefore, hormonally mediated tumour promotion by minoxidil does not represent a carcinogenic risk to humans.

Teratogenicity

Animal reproduction toxicity studies in rats and rabbits have shown signs of maternal toxicity and a risk to the foetus at exposure levels that are very high compared to those, intended for human exposure. A low, albeit remote, risk of foetal harm is possible in humans.

Fertility

Minoxidil doses greater than 9 mg/kg (at least 25-fold human exposure) administered subcutaneously in rats were associated with reduced conception and implantation rates as well as reduction in the number of live pups.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Ethanol, Anhydrous

Purified Water

Butylated hydroxytoluene (E321)

Lactic acid

Citric acid anhydrous

Glycerol

Cetyl alcohol

Stearyl Alcohol

Polysorbate 60

Propane/n-Butane/Iso-butane (as propellant)

Nitrogen

6.2 Incompatibilities

Not applicable

6.3 Shelf Life

2 years

6.4 Special Precautions For Storage

Store below 25°C.

Regaine for Men Extra Strength Scalp Foam 5% w/w Cutaneous Foam is extremely flammable.

6.5 Nature And Contents Of Container

A lined aluminium pressurised container with a child-resistant plastic or polypropylene overcap, containing 60 gram of product.

Packs contain either one or three cans. Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

The contents are under pressure. The container should not be punctured or incinerated. The product is extremely flammable and exposure of the container and contents to naked flames should be avoided during use, storage and disposal. Do not expose to temperatures above 50°C.

Any unused product or waste material should be disposed of in accordance with the local requirements.

7. Marketing Authorisation Holder

McNeil Products Limited

Foundation Park

Roxborough Way

Maidenhead

Berkshire SL6 3UG

United Kingdom

8. Marketing Authorisation Number(S)

PL 15513/0134

9. Date Of First Authorisation/Renewal Of The Authorisation

07/10/2010

10. Date Of Revision Of The Text

07/10/2010

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Tepoxalin

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Scheme

Rec.INN

CAS registry number (Chemical Abstracts Service)

0103475-41-8

Chemical Formula

C20-H20-Cl-N3-O3

Molecular Weight

385

Therapeutic Categories

Analgesic, antipyretic and anti-inflammatory agent

Non-steroidal anti-inflammatory drug, NSAID

Antipsoriatic

Cyclo-oxygenase 2 (COX-2) inhibitor

5-lipoxygenase inhibitor

Chemical Name

5-(p-chlorophenyl)-1-(p-methoxyphenyl)-N-methylpyrazole-3-propionohydroxamic acid

Foreign Names

• Tepoxalinum (Latin)
• Tepoxalin (German)
• Tepoxaline (French)
• Tepoxalina (Spanish)

Generic Names

• Tepoxalin (OS: USAN)
• ORF 20485 (IS: Ortho)
• RWJ 20485 (IS)

Brand Names

• Zubrin (veterinary use)
  Essex Tierarzneimittel, Germany; Galena, Finland; Schering-Plough, Sweden; Schering-Plough Animal, Norway; Schering-Plough Animal Health, Australia; Schering-Plough Animal Health, Belgium; Schering-Plough Animal Health, United States; Schering-Plough Vet, Italy; Schering-Plough Veterinary, United Kingdom; Veterinaria, Switzerland

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