VITAROS 300 micrograms, cream (alprostadil)

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Terrain, posology, cost, efficacy and driving

	Prostaglandin E1				Phosphodiesterase type 5 inhibitors
	Vitarosalprostadil	Edexalprostadil	Caverjectalprostadil	Musealprostadil	Viagrasildénafil	Cialistadalafil	Levitravardénafil	Spedraavanafil
Terrain	Adult Man, + 18 years	Adult Man, + 15 years	Adult Man, + 15 years	Adult Man, + 15 years	Adult Man, + 18 years	Adult Man, + 18 years	Adult Man, + 18 years	Adult Man, + 18 years
Posology	1 unidose 1 time per day 2 to 3 times per week.	5 to 20 µg 1 time per day 1 to 2 time per week.	5 to 20 µg 1 time per day 1 to 2 time per week.	1 stick 1 to 2 time per day. Maximum 7 sticks per week.	1 tablet 1 time per day.	2.5 mg and 5 mg: 1 tablet 1 time per day. 10 and 20 mg: 1 tablet 1 time per day 1 to 2 time per week.	1 tablet 1 time per day.	1 tablet 1 time per day.
Dose cost	10.05 €	11.47 €	10.79 €	16.50 - 18.90 - 23.60 €	6.35 (Ge) to 12.62 € (VIAGRA)	8.95 €	10.54 €	6.33 €
Repayment rate	0%	0%	0%	0%	0%	0%	0%	0%
Action delay	5 to 30 mn	5 to 10 mn	5 to 10 mn	5 to 10 mn	60 mn	30 mn	25-60 mn	30 mn
Action duration	1 to 2 h	30 to 60 mn	30 to 60 mn	30 to 60 mn	4 h	17 h	4 h	6 à 17 h
Actual benefit (French SMR)	low	medium	medium	-	high	high	high	-
Improvement of actual benefit (French ASMR)	no therapeutic progress (V)
Driving	level 1	level 1	level 1	level 1	level 1	level 1	level 1	level 1

(all lines shown)

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Help?

Aide : les résultats d'essai clinique (click to hide)

Les résultats sont présentés à l'aide de diagramme en bâton. Le premier bâton en gris clair est celui du nouveau médicament, le ou les suivants sont ceux des comparateurs. Les bâtons des comparateurs indiquent le résultat de l'analyse statistique (valeur de petit p pour un test de supériorité, ou non-infériorité)

Clinical study results

The IIEF questionnaire (International Index of Erectile Function) is an auto-questionnaire evaluating several aspects of male sexuality. Scores should be interpretated as follows: 26 to 30 = no erectile dysfunction / 22 to 25 = mild erectile dysfunction / 17 to 21 = mild to moderate erectile dysfunction / 11 to 16 = moderate erectile dysfunction / 6 to 10 = severe erectile dysfunction / 0 to 5 = non interpretable.

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Help?

Aide : les boîtes arc-en-ciel des contre-indications (click to hide)

Dans les boîtes arc-en-ciel, les médicaments sont en colonne et les contre-indications sont dans des rectangles en dessous. Les colonnes occupées par chaque rectangle indiquent quels médicaments possèdent la contre-indication.

À chaque médicament est associé une couleur. La couleur d'une contre-indications est la moyenne des couleurs des médicaments concernés.

Cliquez sur le nom d'un comparateur pour effectuer une comparaison 2 à 2, avec les contre-indications triées par chapitre CIM10.

Exemple légendé :

Contraindications

Table Rainbow boxes

Prostaglandin E1				Phosphodiesterase type 5 inhibitors
Vitaros alprostadil	Muse alprostadil	Edex alprostadil	Caverject alprostadil	Viagra sildenafil	Levitra vardenafil	Spedra avanafil	Cialis tadalafil

Age

Vitaros
Muse
Edex
Caverject
Viagra
Levitra
Spedra
Cialis

Child below 18 : contraindicated

Child : contraindicated

Child below 15 : contraindicated

Child below 18 : contraindicated

Pathology contraindicating sexual activity

Vitaros : contraindicated
Muse : contraindicated
Edex : contraindicated
Caverject : contraindicated
Viagra : contraindicated
Levitra : contraindicated
Spedra : contraindicated
Cialis : contraindicated

Female

Loss of vision in one eye due to anterior ischemic non-arteritic optic neuropathy

Viagra : contraindicated
Levitra : contraindicated
Spedra : contraindicated
Cialis : contraindicated

Hypotension

Viagra : contraindicated
Levitra : contraindicated
Spedra : contraindicated
Cialis : contraindicated

History of myocardial infarction

Viagra : contraindicated
Levitra : contraindicated
Spedra : contraindicated
Cialis : contraindicated

History of cerebrovascular events

Viagra : contraindicated
Levitra : contraindicated
Cialis : contraindicated

Hypersensibility to prostaglandins

Vitaros : contraindicated
Muse : contraindicated
Edex : contraindicated
Caverject : contraindicated

Sexual intercourse without a condom with childbearing age or pregnant women

Vitaros : contraindicated
Muse : contraindicated
Edex : contraindicated
Caverject : contraindicated

Predisposition to priapism

Vitaros : contraindicated
Muse : contraindicated
Edex : contraindicated
Caverject : contraindicated

Anatomic malformation of penis

Vitaros : contraindicated
Muse : contraindicated
Edex : contraindicated
Caverject : contraindicated

Retinitis pigmentosa

Viagra : contraindicated
Levitra : contraindicated
Spedra : contraindicated

Severe hepatic failure

Viagra : contraindicated
Levitra : contraindicated
Spedra : contraindicated

Balanitis

Vitaros : contraindicated
Muse : contraindicated

Male uretritis

Vitaros : contraindicated
Muse : contraindicated

Port of penile implant

Edex : contraindicated
Caverject : contraindicated

Anginous pain during sexual intercourses

Spedra : contraindicated
Cialis : contraindicated

Arterial hypertension

Spedra : contraindicated
Cialis : contraindicated (non-controlled)

(non-controlled)

Severe renal failure

Spedra : contraindicated
Cialis : unadvised

End-stage renal failure requiring dialysis

Levitra : contraindicated

History of severe heart rhythm disorders

Spedra : contraindicated

History of cardiac failure

Cialis : contraindicated

Non-controlled heart rhythm disorders

Cialis : contraindicated

Syncope

Vitaros : contraindicated

Orthostatic Hypotension

Vitaros : contraindicated

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Help?

Aide : les boîtes arc-en-ciel des interactions (click to hide)

Dans les boîtes arc-en-ciel, les médicaments sont en colonne et les interactions sont dans des rectangles en dessous. Les colonnes occupées par chaque rectangle indiquent quels médicaments possèdent l'interaction.

Seules les interactions de niveau "contraindicated" ou "unadvised" figurent. À chaque médicament est associé une couleur. La couleur d'une interaction est la moyenne des couleurs des médicaments concernés.

Cliquez sur le nom d'un comparateur pour effectuer une comparaison 2 à 2.

Exemple légendé :

Interactions (contraindicated and unadvised)

Table Rainbow boxes

Prostaglandin E1				Phosphodiesterase type 5 inhibitors
Vitaros alprostadil	Muse alprostadil	Edex alprostadil	Caverject alprostadil	Viagra sildenafil	Levitra vardenafil	Spedra avanafil	Cialis tadalafil

Nitro and related derivatives

Viagra : contraindicated
Levitra : contraindicated
Spedra : contraindicated
Cialis : contraindicated

Riociguat

Viagra : contraindicated
Levitra : contraindicated
Spedra : contraindicated
Cialis : contraindicated

Ritonavir-boosted protease inhibitors

Viagra : unadvised
Levitra : contraindicated
Spedra : contraindicated
Cialis : unadvised

Doxazosin

Viagra : unadvised
Levitra : unadvised
Spedra : unadvised
Cialis : unadvised

Telaprevir

Viagra : unadvised
Levitra : unadvised
Spedra : contraindicated

Itraconazole

Levitra : unadvised
Spedra : contraindicated

Ketoconazole

Levitra : unadvised
Spedra : contraindicated

Grapefruit juice

Levitra : unadvised
Spedra : unadvised

Ombitasvir + paritaprevir

Viagra : contraindicated

Clarithromycin

Spedra : contraindicated

Telithromycin

Spedra : contraindicated

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Help?

Aide : les boîtes arc-en-ciel des effets indésirables (click to hide)

Dans les boîtes arc-en-ciel, les médicaments sont en colonne et les effets indésirables sont dans des rectangles en dessous. Les colonnes occupées par chaque rectangle indiquent quels médicaments possèdent l'effet. Seuls les effets graves, frequents ou very frequents sont affichés.

Cliquez sur le nom d'un comparateur pour effectuer une comparaison 2 à 2, avec les effets classés par classes d'organe.

Attention, l'ordre des médicaments n'est pas forcément le même que pour les contre-indications et les interactions, car ils sont triés en fonction de leur similarité en terme d'effets indésirables.

Exemple légendé :

Adverse effects (frequents, very frequents or serious)

Table Rainbow boxes

Prostaglandin E1				Phosphodiesterase type 5 inhibitors
Vitaros alprostadil	Caverject alprostadil	Edex alprostadil	Muse alprostadil	Levitra vardénafil	Viagra sildénafil	Cialis tadalafil	Spedra avanafil

Priapism

Priapism
Effet grave

Vitaros : infrequent
Caverject : infrequent
Edex : infrequent
Muse : rare
Levitra : rare
Viagra : rare
Cialis : rare

Erection prolonged

Erection prolonged
Effet grave

Vitaros : frequent
Caverject : frequent
Edex : frequent
Muse : rare
Levitra : infrequent
Viagra : rare
Cialis : rare

Headache

Muse : frequent
Levitra : very frequent
Viagra : very frequent
Cialis : frequent
Spedra : frequent

Penile pain

Vitaros : frequent
Caverject : very frequent
Edex : very frequent
Muse : very frequent

Vulvovaginal burning sensation

Vitaros : frequent
Muse : frequent

Urethral pain

Vitaros : frequent
Muse : very frequent

Hot flush

Levitra : frequent
Viagra : frequent
Cialis : frequent
Spedra : frequent

Nasal congestion

Levitra : frequent
Viagra : frequent
Cialis : frequent
Spedra : frequent

Angina pectoris

Angina pectoris
Effet grave

Levitra : rare
Viagra : rare
Cialis : rare
Spedra : rare

Chest pain

Chest pain
Effet grave

Levitra : rare
Viagra : infrequent
Cialis : infrequent
Spedra : rare

Dyspepsia

Levitra : frequent
Viagra : frequent
Cialis : frequent

Nonarteritic anterior ischemic optic neuropathy

Nonarteritic anterior ischemic optic neuropathy
Effet grave

Levitra : unknown frequency
Viagra : rare
Cialis : rare

Seizure

Seizure
Effet grave

Levitra : rare
Viagra : rare
Cialis : rare

Myocardial infarction

Myocardial infarction
Effet grave

Levitra : rare
Viagra : rare
Cialis : rare

Ventricular arrhythmia

Ventricular arrhythmia
Effet grave

Levitra : rare
Viagra : rare
Cialis : rare

Angioedema

Angioedema
Effet grave

Levitra : infrequent
Viagra : rare
Cialis : rare

Drug hypersensitivity

Drug hypersensitivity
Effet grave

Levitra : rare
Viagra : infrequent
Cialis : infrequent

Dizziness

Muse : frequent
Levitra : frequent
Viagra : frequent

Penile burning sensation

Vitaros : frequent
Caverject : very frequent

Peyronie's disease

Caverject : frequent
Edex : frequent

Injection site bruising

Caverject : frequent
Edex : frequent

Injection site haematoma

Caverject : frequent
Edex : frequent

Supraventricular extrasystoles

Supraventricular extrasystoles
Effet grave

Caverject : infrequent
Edex : infrequent

Haemorrhagic stroke

Haemorrhagic stroke
Effet grave

Viagra : rare
Cialis : rare

Ischaemic stroke

Ischaemic stroke
Effet grave

Viagra : rare
Cialis : rare

Transient ischaemic attack

Transient ischaemic attack
Effet grave

Viagra : rare
Cialis : rare

Retinal vascular occlusion

Retinal vascular occlusion
Effet grave

Viagra : rare
Cialis : rare

Sudden cardiac death

Sudden cardiac death
Effet grave

Viagra : rare
Cialis : rare

Stevens-Johnson syndrome

Stevens-Johnson syndrome
Effet grave

Viagra : rare
Cialis : rare

Fibrosis of the corpora cavernosa

Edex : frequent

Muscle spasms

Caverject : frequent

Rash

Vitaros : frequent

Balanitis

Vitaros : frequent

Genital discomfort

Vitaros : frequent

Genital erythema

Vitaros : frequent

Genital pain male

Vitaros : frequent

Genital pruritus male

Vitaros : frequent

Non-specific vaginitis

Vitaros : frequent

Penile erythema

Vitaros : frequent

Penile oedema

Vitaros : frequent

Penis disorder

Vitaros : frequent

Gastrooesophageal reflux disease

Cialis : frequent

Dorsal pain

Cialis : frequent

Myalgia

Cialis : frequent

Pain in extremity

Cialis : frequent

Dermatitis exfoliative

Dermatitis exfoliative
Effet grave

Cialis : rare

Hypotension symptomatic

Muse : frequent

Urethral bleeding

Muse : frequent

Testicular pain

Muse : frequent

Vaginal itching

Muse : frequent

Chromatopsia

Viagra : frequent

Vision blurred

Viagra : frequent

Visual disturbance

Viagra : frequent

Nausea

Viagra : frequent

Atrial fibrillation

Atrial fibrillation
Effet grave

Viagra : rare

Lyell's syndrome

Lyell's syndrome
Effet grave

Viagra : rare

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Help?

Aide : le tableau des excipients à effet notoire (click to hide)

Le tableau liste les excipients à effet notoire de chaque médicament (notez que les excipients peuvent varier dans le cas de génériques).

Légende :

excipient présent

Excipients with known effect

	Prostaglandin E1				Phosphodiesterase type 5 inhibitors
	Vitarosalprostadil	Edexalprostadil	Caverjectalprostadil	Musealprostadil	Viagrasildénafil	Cialistadalafil	Levitravardénafil	Spedraavanafil
Lactose
(aucun)
(aucun)

(all lines shown)

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Identification and documents

	Prostaglandin E1				Phosphodiesterase type 5 inhibitors
	Vitarosalprostadil	Edexalprostadil	Caverjectalprostadil	Musealprostadil	Viagrasildénafil	Cialistadalafil	Levitravardénafil	Spedraavanafil
International nonproprietary name	alprostadil	alprostadil	alprostadil	alprostadil	sildenafil	tadalafil	vardenafil	avanafil
Dosage	300 µg	10 and 20 µg	10 and 20 µg	250 µg, 500 µg and 1000 µg	25 mg, 50 mg and 100 mg	2.5 mg, 5 mg, 10 mg and 20 mg	5 mg, 10 mg and 20 mg	50 mg, 100 mg and 200 mg
Dosage form	Cream	Powder and solvent for solution for injection	Powder and solvent for solution for injection	Stick for urethral use	Tablet and orodispersible tablet (Ge)	Tablet	Tablet and orodispersible tablet	Tablet
Route	Topical	Intracavernous	Intracavernous	Intraurethral	Oral	Oral	Oral	Oral
Presentation	Single-dose unit	Cartridge	Syringe	Stick
Companies	MAJORELLE	UCB PHARMA	PFIZER	MEDA AB	PFIZER	LILLY	BAYER	MENARINI
Marketing date	2013	1997	1994	1999	1998	2002	2003	2013
Summary of product Characteristics (SPC)								
Patient leaflet								
Opinion of the French transparency commission						

(all lines shown)

	Prostaglandin E1				Phosphodiesterase type 5 inhibitors
	Vitarosalprostadil	Edexalprostadil	Caverjectalprostadil	Musealprostadil	Viagrasildénafil	Cialistadalafil	Levitravardénafil	Spedraavanafil
Immune system disorders
Drug hypersensitivity					Infrequent adverse effect	Infrequent adverse effect	Rare adverse effect
Angioedema					Rare adverse effect	Rare adverse effect	Infrequent adverse effect
Nervous system disorders
Ischaemic stroke					Rare adverse effect	Rare adverse effect
Haemorrhagic stroke					Rare adverse effect	Rare adverse effect
Transient ischaemic attack					Rare adverse effect	Rare adverse effect
Dizziness				Frequent adverse effect	Frequent adverse effect		Frequent adverse effect
Headache				Frequent adverse effect	Very frequent adverse effect	Frequent adverse effect	Very frequent adverse effect	Frequent adverse effect
Seizure					Rare adverse effect	Rare adverse effect	Rare adverse effect
Eye disorders
Nonarteritic anterior ischemic optic neuropathy					Rare adverse effect	Rare adverse effect	Adverse effect with unknown frequency
Retinal vascular occlusion					Rare adverse effect	Rare adverse effect
Chromatopsia					Frequent adverse effect
Visual disturbance					Frequent adverse effect
Vision blurred					Frequent adverse effect
Cardiac disorders
Supraventricular extrasystoles		Infrequent adverse effect	Infrequent adverse effect
Atrial fibrillation					Rare adverse effect
Ventricular arrhythmia					Rare adverse effect	Rare adverse effect	Rare adverse effect
Angina pectoris					Rare adverse effect	Rare adverse effect	Rare adverse effect	Rare adverse effect
Myocardial infarction					Rare adverse effect	Rare adverse effect	Rare adverse effect
Sudden cardiac death					Rare adverse effect	Rare adverse effect
Vascular disorders
Hypotension symptomatic				Frequent adverse effect
Hot flush					Frequent adverse effect	Frequent adverse effect	Frequent adverse effect	Frequent adverse effect
Respiratory, thoracic and mediastinal disorders
Nasal congestion					Frequent adverse effect	Frequent adverse effect	Frequent adverse effect	Frequent adverse effect
Gastrointestinal disorders
Gastrooesophageal reflux disease						Frequent adverse effect
Dyspepsia					Frequent adverse effect	Frequent adverse effect	Frequent adverse effect
Nausea					Frequent adverse effect
Skin and subcutaneous tissue disorders
Dermatitis exfoliative						Rare adverse effect
Lyell's syndrome					Rare adverse effect
Stevens-Johnson syndrome					Rare adverse effect	Rare adverse effect
Rash	Frequent adverse effect
Musculoskeletal and connective tissue disorders
Myalgia						Frequent adverse effect
Muscle spasms			Frequent adverse effect
Dorsal pain						Frequent adverse effect
Pain in extremity						Frequent adverse effect
Renal and urinary disorders
Urethral pain	Frequent adverse effect			Very frequent adverse effect
Urethral bleeding				Frequent adverse effect
Reproductive system and breast disorders
Penile pain	Frequent adverse effect	Very frequent adverse effect	Very frequent adverse effect	Very frequent adverse effect
Penile erythema	Frequent adverse effect
Fibrosis of the corpora cavernosa		Frequent adverse effect
Peyronie's disease		Frequent adverse effect	Frequent adverse effect
Penile oedema	Frequent adverse effect
Penile burning sensation	Frequent adverse effect		Very frequent adverse effect
Penis disorder	Frequent adverse effect
Priapism	Infrequent adverse effect	Infrequent adverse effect	Infrequent adverse effect	Rare adverse effect	Rare adverse effect	Rare adverse effect	Rare adverse effect
Testicular pain				Frequent adverse effect
Vaginal itching				Frequent adverse effect
Genital pruritus male	Frequent adverse effect
Non-specific vaginitis	Frequent adverse effect
Balanitis	Frequent adverse effect
Genital pain male	Frequent adverse effect
Genital erythema	Frequent adverse effect
Genital discomfort	Frequent adverse effect
Erection prolonged	Frequent adverse effect	Frequent adverse effect	Frequent adverse effect	Rare adverse effect	Rare adverse effect	Rare adverse effect	Infrequent adverse effect
Vulvovaginal burning sensation	Frequent adverse effect			Frequent adverse effect
General disorders and administration site conditions
Injection site bruising		Frequent adverse effect	Frequent adverse effect
Chest pain					Infrequent adverse effect	Infrequent adverse effect	Rare adverse effect	Rare adverse effect
Injection site haematoma		Frequent adverse effect	Frequent adverse effect
(aucun)

Show all Show notable absences

	Vitaros	Caverject
Cardiac disorders		Supraventricular extrasystoles
Skin and subcutaneous tissue disorders	Rash
Musculoskeletal and connective tissue disorders		Muscle spasms
Renal and urinary disorders	Urethral pain
Reproductive system and breast disorders	Penile erythema Penile oedema Penis disorder Genital pruritus male Non-specific vaginitis Balanitis Genital pain male Genital erythema Genital discomfort Vulvovaginal burning sensation	Peyronie's disease
General disorders and administration site conditions		Injection site bruising Injection site haematoma

Reproductive system and breast disorders	Penile pain Penile burning sensation Priapism Erection prolonged

	Vitaros	Edex
Cardiac disorders		Supraventricular extrasystoles
Skin and subcutaneous tissue disorders	Rash
Renal and urinary disorders	Urethral pain
Reproductive system and breast disorders	Penile erythema Penile oedema Penile burning sensation Penis disorder Genital pruritus male Non-specific vaginitis Balanitis Genital pain male Genital erythema Genital discomfort Vulvovaginal burning sensation	Fibrosis of the corpora cavernosa Peyronie's disease
General disorders and administration site conditions		Injection site bruising Injection site haematoma

Reproductive system and breast disorders	Penile pain Priapism Erection prolonged

	Vitaros	Muse
Nervous system disorders		Dizziness Headache
Vascular disorders		Hypotension symptomatic
Skin and subcutaneous tissue disorders	Rash
Renal and urinary disorders		Urethral bleeding
Reproductive system and breast disorders	Penile erythema Penile oedema Penile burning sensation Penis disorder Genital pruritus male Non-specific vaginitis Balanitis Genital pain male Genital erythema Genital discomfort	Testicular pain Vaginal itching

Renal and urinary disorders	Urethral pain
Reproductive system and breast disorders	Penile pain Priapism Erection prolonged Vulvovaginal burning sensation

	Vitaros	Levitra
Immune system disorders		Drug hypersensitivity Angioedema
Nervous system disorders		Dizziness Headache Seizure
Eye disorders		Nonarteritic anterior ischemic optic neuropathy
Cardiac disorders		Ventricular arrhythmia Angina pectoris Myocardial infarction
Vascular disorders		Hot flush
Respiratory, thoracic and mediastinal disorders		Nasal congestion
Gastrointestinal disorders		Dyspepsia
Skin and subcutaneous tissue disorders	Rash
Renal and urinary disorders	Urethral pain
Reproductive system and breast disorders	Penile pain Penile erythema Penile oedema Penile burning sensation Penis disorder Genital pruritus male Non-specific vaginitis Balanitis Genital pain male Genital erythema Genital discomfort Vulvovaginal burning sensation
General disorders and administration site conditions		Chest pain

Reproductive system and breast disorders	Priapism Erection prolonged

	Vitaros	Viagra
		Doxazosin Nitro and related derivatives Ritonavir-boosted protease inhibitors Ombitasvir + paritaprevir Riociguat Telaprevir

	Vitaros	Spedra
		Clarithromycin Doxazosin Nitro and related derivatives Ritonavir-boosted protease inhibitors Itraconazole Grapefruit juice Ketoconazole Riociguat Telaprevir Telithromycin

	Vitaros	Cialis
		Doxazosin Nitro and related derivatives Ritonavir-boosted protease inhibitors Riociguat