Contact Information
Registered Office/ Head Office:
Ashford Laboratories Pvt. Ltd.,
31/36, 5th Floor, Dheeraj Heritage,
S. V. Road, Santacruz (West),
Mumbai (Bombay) - 400 054. India.
Tele- fax: + 91 22 6675 8866
Email:info@ashfordlab.com

Japan Office:
Ashford Laboratories,
4-11-24-1402 Fukae Kitamachi,
Higashi Nada Ku, Kobe 658-0013,
Japan.
Tele- fax: +81 0784 122579
Email:japan@ashfordlab.com
Erectile Dysfunction Drugs
       Erecta™ Oral Gel       Erecta™ film-coated tablets        Erecta Topical Gel       Erecta D™ film-coated tablets        Erectalis™ Once-a-Day film-coated tablets       Erectalis™ Oral Gel        Erecteva™ 5mg film-coated tablets
TOP Erecta™ Oral Gel (Sildenafil citrate eq. to Sildenafil 100mg/ 5g sachet) Sildenafil Oral Gel/ Jelly
Description
Erecta Oral Gel is a breakthrough medicine now available for male erectile dysfunction (ED). ED is also often called impotency or impotence. Chemically, Erecta Oral Gel contains citrate salt of Sildenafil or Sildenafil Citrate. With sexual stimulation, men who have ED will be able to obtain and maintain an erection due to the effects of Erecta Oral Gel.
  Dissolving the gel in your mouth results in faster absorption by the body and a quicker onset of "results".
  The gel is more easily swallowed than tablets and suitable for elderly people or people who have difficulty in swallowing.
  Reduced gastric irritation compared to tablets.

Composition
Each 5 g contains
Sildenafil citrate
Equivalent to Sildenafil ……. 100 mg
Gel base …………………………. q.s.

Indication
For the treatment of erectile dysfunction

Contra Indications
In patients, on nitrate therapy and with a known hypersensitivity to any component of the tablet

Dosage form
Gel

Route of administration
Oral

How to Use
The recommended dose is 50mg per day as needed approx. 1 hour before sexual activity. Based on effectiveness and toleration, the dose may be increased to a maximum recommended dose of 100mg or decreased to 25mg.

Side Effects
Headache, rashness, dizziness, diarrhea, abnormal vision, nasal congestion, dyspepsia and flushing may occur.

Precautions
In patients with bleeding disorders, active peptic ulceration and anatomical deformation of the penis

Drug Interactions
Interaction with Erythromycin, Cimetidine, Ketocanozole, Itracanozole, Rifampicin, is noted.
TOP Erecta™25mg film-coated tablets (Sildenafil citrate eq. to sildenafil 25mg) Erecta™50mg film-coated tablets (Sildenafil citrate eq. to sildenafil 50mg) Erecta™100mg film-coated tablets (Sildenafil citrate eq. to sildenafil 100mg) Erecta™120mg film-coated tablets (Sildenafil citrate eq. to sildenafil 120mg) Sildenafil Citrate Film Coated Tablets
Each tablet contains
25mg, 50mg, 100mg or 120mg of sildenafil (as citrate)

Excipient: Lactose
PHARMACEUTICAL FORM
Film-coated tablet.
25 mg: Blue rounded diamond-shaped tablets
50 mg: Blue rounded diamond-shaped tablets
100 mg: Blue rounded diamond-shaped tablets
120 mg: Blue rounded diamond-shaped tablets

CLINICAL PARTICULARS
Therapeutic indications
Treatment of men with erectile dysfunction, which is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance.

In order for ERECTA to be effective, sexual stimulation is required.

Posology and method of administration
For oral use.
Use in adults-
The recommended dose is 50mg taken as needed approximately one hour before sexual activity. Based on efficacy and toleration, the dose may be increased to 100mg or decreased to 25mg. The maximum recommended dose is 100 mg. The maximum recommended dosing frequency is once per day. If ERECTA is taken with food, the onset of activity may be delayed compared to the fasted state.

Use in the elderly-
Dosage adjustments are not required in elderly patients.

Use in children and adolescents-
ERECTA is not indicated for individuals below 18 years of age.

Contraindications
Hypersensitivity to the active substance or to any of the excipients.

The film coating of the ERECTA tablet contains lactose. ERECTA should not be administered to men with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.

ERECTA is not indicated for use by women.

Overdose
In single dose volunteer studies of doses up to 800mg, adverse reactions were similar to those seen at lower doses, but the incidence rates and severities were increased. Doses of 200mg did not result in increased efficacy but the incidence of adverse reactions (headache, flushing, dizziness, dyspepsia, nasal congestion, altered vision) was increased.

In cases of overdose, standard supportive measures should be adopted as required. Renal dialysis is not expected to accelerate clearance as sildenafil is highly bound to plasma proteins and not eliminated in the urine.
PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties
Pharmacotherapeutic group
Drugs used in erectile dysfunction. ATC Code: G04B E03.

Sildenafil is an oral therapy for erectile dysfunction. In the natural setting, i.e. with sexual stimulation, it restores impaired erectile function by increasing blood flow to the penis.

PHARMACEUTICAL PARTICULARS

List of excipients
Tablet core
microcrystalline cellulose, calcium hydrogen phosphate (anhydrous), croscarmellose sodium, magnesium stearate.

Film coat
hypromellose, titanium dioxide (E171), lactose, triacetin, indigo carmine aluminium lake (E132).

Incompatibilities
Not applicable.

Shelf life
5 years

Special precautions for storage
Do not store above 30°C. Store in the original package, in order to protect from moisture.

Nature and contents of container
PVC/ Aluminum foil blisters in cartons of 2, 4, 8, 10 or 12 tablets.
TOP Erecta Topical Gel (Sildenafil citrate 1% w/w) Sildenafil Topical Gel
Description
To reduce the adverse effects and requirements of repeated Sildenafil Citrate dose to sustain plasma level because of its short duration of action with high liver metabolism, topical gel of Sildenafil Citrate is developed and it is an alternative to oral administration.

Composition
Sildenafil Citrate- 1% w/w
Gel base- q. s.

Indication:
Erectile dysfunction

Dosage form
Gel

Route of administration
Topical
TOP Erecta D™ film-coated tablets (Sildenafil 100 mg + Dapoxetine 60 mg) Sildenafil Citrate + Dapoxetine Hydrochloride Film Coated Tablets
Each film coated tablet contains Sildenafil Citrate eq. to Sildenafil 100 mg + Dapoxetine Hydrochloride Eq. to Dapoxetine 60 mg

Indication
Tablet is indicated for the treatment of erectile dysfunction.
TOP Erectalis™ Once-a-Day 2.5mg film-coated tablets (Tadalafil 2.5mg) Erectalis™5mg film-coated tablets (Tadalafil 5mg) Erectalis™10mg film-coated tablets (Tadalafil 10mg) Erectalis™20mg film-coated tablets (Tadalafil 20mg) Tadalafil Film Coated Tablets
Each tablet contains 2.5mg, 5mg, 10mg or 20mg tadalafil
Excipient: lactose monohydrate.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
The 2.5mg tablets are light orange-yellow and almond shaped
The 5mg tablets are light yellow and almond shaped
The 10mg tablets are light yellow and almond shaped
The 20mg tablets are yellow and almond shaped
CLINICAL PARTICULARS
Therapeutic indications
Treatment of erectile dysfunction in adult males. In order for tadalafil to be effective, sexual stimulation is required.

ERECTALIS is not indicated for use by women.

Posology and method of administration
Method of administration ERECTALIS is available as 2.5mg, 5mg, 10mg and 20mg film-coated tablets for oral use.

Posology
Use in Adult Men
In general, the recommended dose is 10mg taken prior to anticipated sexual activity and with or without food. In those patients in whom tadalafil 10mg does not produce an adequate effect, 20mg might be tried. It may be taken at least 30 minutes prior to sexual activity.

The maximum dose frequency is once per day.

Tadalafil 10mg and 20mg is intended for use prior to anticipated sexual activity and it is not recommended for continuous daily use.

In patients who anticipate a frequent use of ERECTALIS (i.e., at least twice weekly) a once daily regimen with the lowest doses of ERECTALIS might be considered suitable, based on patient choice and the physician's judgement.

In these patients, the recommended dose is 5mg taken once a day at approximately the same time of day. The dose may be decreased to 2.5mg once a day based on individual tolerability.

The appropriateness of continued use of the daily regimen should be reassessed periodically.

Use in Elderly Men
Dose adjustments are not required in elderly patients.

Use in Men with Diabetes
Dose adjustments are not required in diabetic patients.

Pediatric population
ERECTALIS should not be used in individuals below 18 years of age.

Contraindications
Hypersensitivity to the active substance or to any of the excipients.

Agents for the treatment of erectile dysfunction, including ERECTALIS, must not be used in men with cardiac disease for whom sexual activity is inadvisable. Physicians should consider the potential cardiac risk of sexual activity in patients with pre-existing cardiovascular disease.

Overdose
Single doses of up to 500mg have been given to healthy subjects, and multiple daily doses up to 100mg have been given to patients. Adverse events were similar to those seen at lower doses.

In cases of overdose, standard supportive measures should be adopted, as required. Haemodialysis contributes negligibly to tadalafil elimination.
PHARMACOLOGICAL PROPERTIES
Pharmacotherapeutic group
Drugs used in erectile dysfunction. ATC code: G04BE08.

Mechanism of action
Tadalafil is a selective, reversible inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). When sexual stimulation causes the local release of nitric oxide, inhibition of PDE5 by tadalafil produces increased levels of cGMP in the corpus cavernosum. This results in smooth muscle relaxation and inflow of blood into the penile tissues, thereby producing an erection. Tadalafil has no effect in the absence of sexual stimulation.
PHARMACEUTICAL PARTICULARS
List of excipients
Tablet core
Lactose monohydrate, Croscarmellose sodium, Hydroxypropylcellulose, Microcrystalline cellulose, Sodium laurilsulfate, Magnesium stearate

2.5 mg Film-coat
Lactose monohydrate, Hypromellose, Triacetin, Titanium dioxide (E171), Iron oxide yellow (E172), Iron oxide red (E172), Talc

5 mg, 10mg and 20mg Film-coat
Lactose monohydrate, Hypromellose, Triacetin, Titanium dioxide (E171), Iron oxide yellow (E172), Talc

Shelf life
3 years

Special precautions for storage
Store in the original package in order to protect from moisture. For Tadalafil 5mg - Do not store above 25°C. For Tadalafil 2.5mg, 10mg and 20mg - Do not store above 30°C.

Nature and contents of container
Aluminium/PVC/PE/ PCTFE blisters in cartons of 2, 4, 8, 10, 12, 14 and 28 film-coated tablets.
TOP Erectalis™ Oral Gel (Tadalafil 20mg/ 5g sachet) Tadalafil Oral Gel/ Jelly
Description
Erectalis Oral Gel treats erectile dysfunction (Impotence) very effectively irrespective of age of a man and the period since when he is suffering from Impotence. Erectalis Oral Gel does not cure Erectile Dysfunction but helps men suffering from erection problem to have sexual intercourse again with more pleasure and sexual satisfaction.
  Dissolving the gel in your mouth results in faster absorption by the body and a quicker onset of "results".
  The gel is more easily swallowed than tablets and suitable for elderly people or people who have difficulty in swallowing.
  Reduced gastric irritation compared to tablets.

Composition
Each 5 g contains Tadalafil …………….. 20mg Gel base …………………………. q.s.

Indication
For the treatment of erectile dysfunction

Contra Indications
Hypersensitivity to the active substance or to any of the excipients.

Dosage form
Gel

Route of administration
Oral

How to Use
In general, the recommended dose is 10mg taken prior to anticipated sexual activity and with or without food. In those patients in whom tadalafil 10mg does not produce an adequate effect, 20mg might be tried. It may be taken at least 30 minutes prior to sexual activity. The maximum dose frequency is once per day. Tadalafil 10mg and 20mg is intended for use prior to anticipated sexual activity and it is not recommended for continuous daily use.

Side Effects
Headache, myalgia (muscle pain), dyspepsia (upset stomach following meals) and back pain. The severities of these Tadalafil side effects were minimized with lower doses of Erectalis.

Precautions
Treatments for erectile dysfunction, including Tadalafil should not be used in men with cardiac disease for whom sexual activity is inadvisable. Physicians should consider the potential cardiac risk of sexual activity in patients with pre-existing cardiovascular disease. Patients who experience erections lasting 4 hours or more should be instructed to seek immediate medical assistance. If priapism is not treated immediately, penile tissue damage and permanent loss of potency may result.

Drug Interactions
The breakdown and elimination of tadalafil from the body may be decreased by erythromycin, ketoconazole (Nizoral), itraconazole (Sporanox), indinavir (Crixivan) and ritonavir (Norvir). Therefore, these drugs may increase the levels of tadalafil in the blood. If these drugs are being used at the same time as tadalafil, the dose of tadalafil should be reduced in order to avoid side effects from high levels of tadalafil.
TOP Erecteva™ 5mg film-coated tablets (vardenafil 5mg) Erecteva™10mg film-coated tablets (vardenafil 10mg) Erecteva™20mg film-coated tablets (vardenafil 20mg) Vardenafil Film Coated Tablets
Each tablet contains 5 mg, 10 mg or 20 mg of vardenafil (as hydrochloride trihydrate).
PHARMACEUTICAL FORM
Film-coated tablet. ERECTEVA 5 mg film-coated tablets: Orange round tablets ERECTEVA 10 mg film-coated tablets: Orange round tablets ERECTEVA 20 mg film-coated tablets: Orange round tablets
CLINICAL PARTICULARS
For oral use.
Therapeutic indications
Treatment of erectile dysfunction in adult men. Erectile dysfunction is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance.

In order for ERECTEVA to be effective, sexual stimulation is required.

ERECTEVA is not indicated for use by women.

Posology and method of administration
Use in adult men
The recommended dose is 10 mg taken as needed approximately 25 to 60 minutes before sexual activity. Based on efficacy and tolerability the dose may be increased to 20 mg or decreased to 5 mg. The maximum recommended dose is 20 mg. The maximum recommended dosing frequency is once per day. ERECTEVA can be taken with or without food. The onset of activity may be delayed if taken with a high fat meal

Use in children and adolescents
ERECTEVA is not indicated for individuals below 18 years of age. There is no relevant indication for use of ERECTEVA in children.

Contraindications
Hypersensitivity to the active substance or to any of the excipients.

The coadministration of vardenafil with nitrates or nitric oxide donors (such as amyl nitrite) in any form is contraindicated.

Overdose
In single dose volunteer studies, doses up to and including 80 mg per day were tolerated without exhibiting serious adverse reactions.

When vardenafil was administered in higher doses and more frequently than the recommended dosing regimen (40 mg twice daily) cases of severe back pain have been reported. This was not associated with any muscle or neurological toxicity.

In cases of overdose, standard supportive measures should be adopted as required. Renal dialysis is not expected to accelerate clearance, as vardenafil is highly bound to plasma proteins and not significantly eliminated in the urine.
PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties
Pharmacotherapeutic group
Medicinal product used in erectile dysfunction, ATC code: G04BE09

Vardenafil is an oral therapy for the improvement of erectile function in men with erectile dysfunction. In the natural setting, i.e. with sexual stimulation it restores impaired erectile function by increasing blood flow to the penis.
PHARMACEUTICAL PARTICULARS
List of excipients
Tablet core
crospovidone, magnesium stearate, microcrystalline cellulose, silica, colloidal anhydrous

Film coat
macrogol 400, hypromellose, titanium dioxide (E171), ferric oxide yellow (E172), ferric oxide red (E172)

Shelf life
3 years

Special precautions for storage
This medicinal product does not require any special storage conditions.

4.4 Nature and contents of container
PP/Aluminium foil blisters in cartons of 2, 4, 8 and 12 tablets.

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