medsgo.ph Open in urlscan Pro
188.166.204.234  Public Scan

URL: https://medsgo.ph/prescription-medicines/erectile-dysfunction/erecfil-100-sildenafil-100mg-film-coated-tablet-8s-c...
Submission: On July 18 via api from US — Scanned from SG

Form analysis 15 forms found in the DOM

Name: search_formGET https://medsgo.ph/

<form action="https://medsgo.ph/" name="search_form" method="get" class="cm-processed-form">
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  <input type="hidden" name="security_hash" class="cm-no-hide-input" value="7222536b9a8d8f09d734d82459d32530">
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Name: call_requests_form_mainPOST https://medsgo.ph/

<form name="call_requests_form_main" id="form_call_request_933" action="https://medsgo.ph/" method="post" class="cm-ajax cm-ajax-full-render cm-processing-personal-data cm-processed-form" data-ca-processing-personal-data-without-click="true">
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  <div class="ty-control-group">
    <label class="ty-control-group__title" for="call_data_call_request_933_name">Your name</label>
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  <div class="ty-control-group">
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  <div class="ty-control-group">
    <label for="call_data_call_request_933_convenient_time_from" class="ty-control-group__title">Convenient time</label>
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      <span class="ty-icon ty-icon-help-circle ty-gdpr-agreement--icon"></span>
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    <div id="gdpr_agreements_call_requests_933_error_wrapper"></div>
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  <!-- Inline script moved to the bottom of the page -->
  <div class="cm-block-add-subscribe">
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  <div class="buttons-container">
    <button class="ty-btn__primary ty-btn__big cm-form-dialog-closer ty-btn ty-btn" type="submit" name="dispatch[call_requests.request]"><span><bdi>Submit</bdi></span></button>
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</form>

Name: track_order_quickPOST https://medsgo.ph/

<form action="https://medsgo.ph/" method="POST" class="cm-ajax cm-post cm-ajax-full-render cm-processed-form" name="track_order_quick">
  <input type="hidden" name="result_ids" value="track_orders_block_*">
  <input type="hidden" name="return_url" value="index.php?fbclid=IwAR1maDQ7cPYNZXtOjPweKG2gCcrtr9psu5C829DZb-8W1m7K5Xhq42SP4bU&amp;dispatch=products.view&amp;product_id=36790">
  <div class="ty-account-info__orders-txt">Track my order(s)</div>
  <div class="ty-account-info__orders-input ty-control-group ty-input-append">
    <label for="track_order_item935" class="cm-required hidden">Track my order(s)</label>
    <input type="text" size="20" class="ty-input-text cm-hint" id="track_order_item935" name="hint_track_data" value="Order ID/E-mail">
    <button title="Go" class="ty-btn-go" type="submit"><span class="ty-icon ty-icon-right-dir ty-btn-go__icon"></span>
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    <input type="hidden" name="dispatch" value="orders.track_request">
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  <input type="hidden" name="security_hash" class="cm-no-hide-input" value="7222536b9a8d8f09d734d82459d32530">
</form>

Name: popup935_formPOST https://medsgo.ph/

<form name="popup935_form" action="https://medsgo.ph/" method="post" class="cm-ajax cm-ajax-full-render cm-processed-form">
  <input type="hidden" name="result_ids" value="popup935_login_popup_form_container">
  <input type="hidden" name="login_block_id" value="popup935">
  <input type="hidden" name="quick_login" value="1">
  <input type="hidden" name="return_url" value="index.php?fbclid=IwAR1maDQ7cPYNZXtOjPweKG2gCcrtr9psu5C829DZb-8W1m7K5Xhq42SP4bU&amp;dispatch=products.view&amp;product_id=36790">
  <input type="hidden" name="redirect_url" value="index.php?fbclid=IwAR1maDQ7cPYNZXtOjPweKG2gCcrtr9psu5C829DZb-8W1m7K5Xhq42SP4bU&amp;dispatch=products.view&amp;product_id=36790">
  <div class="ty-control-group">
    <label for="login_popup935" class="ty-login__filed-label ty-control-group__label cm-required cm-trim cm-email">E-mail</label>
    <input type="text" id="login_popup935" name="user_login" size="30" value="" class="ty-login__input cm-focus">
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  <div class="ty-control-group ty-password-forgot">
    <label for="psw_popup935"
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    <input type="password" id="psw_popup935" name="password" size="30" value="" class="ty-login__input" maxlength="32">
  </div>
  <div class="ty-login-reglink ty-center">
    <a class="ty-login-reglink__a" href="https://medsgo.ph/profiles-add/" rel="nofollow">Register for a new account</a>
  </div> Or sign-in with another identity provider: <p class="ty-text-center">
    <input type="hidden" name="redirect_url"
      value="index.php?fbclid=IwAR1maDQ7cPYNZXtOjPweKG2gCcrtr9psu5C829DZb-8W1m7K5Xhq42SP4bU&amp;dispatch=products.view&amp;product_id=36790"><a class="cm-login-provider ty-hybrid-auth__icon" data-idp="1" data-provider="facebook"><img src="https://medsgo.ph/design/themes/responsive/media/images/addons/hybrid_auth/icons/flat_32x32/facebook.png" title="facebook" alt="facebook"></a><a class="cm-login-provider ty-hybrid-auth__icon" data-idp="2" data-provider="google"><img src="https://medsgo.ph/design/themes/responsive/media/images/addons/hybrid_auth/icons/flat_32x32/google.png" title="google" alt="google"></a>
  </p>
  <div class="buttons-container clearfix">
    <div class="ty-login__remember-me">
      <label for="remember_me_popup935" class="ty-login__remember-me-label"><input class="checkbox" type="checkbox" name="remember_me" id="remember_me_popup935" value="Y">Remember me</label>
    </div>
    <button class="ty-btn__login ty-btn__secondary ty-btn" type="submit" name="dispatch[auth.login]"><span><bdi>Sign in</bdi></span></button>
  </div>
  <input type="hidden" name="security_hash" class="cm-no-hide-input" value="7222536b9a8d8f09d734d82459d32530">
</form>

Name: product_form_36790POST https://medsgo.ph/

<form action="https://medsgo.ph/" method="post" name="product_form_36790" enctype="multipart/form-data" class="cm-disable-empty-files cm-ajax cm-ajax-full-render cm-ajax-status-middle cm-processed-form">
  <input type="hidden" name="result_ids" value="cart_status*,wish_list*,checkout*,account_info*,abt__ut2_wishlist_count">
  <input type="hidden" name="redirect_url" value="index.php?fbclid=IwAR1maDQ7cPYNZXtOjPweKG2gCcrtr9psu5C829DZb-8W1m7K5Xhq42SP4bU&amp;dispatch=products.view&amp;product_id=36790">
  <input type="hidden" name="product_data[36790][product_id]" value="36790">
  <div class="pr-row-mix ut2-pb__price-wrap prices-container">
    <div class="ty-product-prices">
      <div class="ut2-pb__price-actual">
        <span class="cm-reload-36790 ty-price-update" id="price_update_36790">
          <input type="hidden" name="appearance[show_price_values]" value="1">
          <input type="hidden" name="appearance[show_price]" value="1">
          <span class="ty-no-price">Contact us for a price</span>
          <!--price_update_36790--></span>
      </div>
      <span class="cm-reload-36790" id="old_price_update_36790">
        <input type="hidden" name="appearance[show_old_price]" value="1">
        <!--old_price_update_36790--></span>
      <div class="ut2-pb__price-old">
        <span class="cm-reload-36790" id="line_discount_update_36790">
          <input type="hidden" name="appearance[show_price_values]" value="1">
          <input type="hidden" name="appearance[show_list_discount]" value="1">
          <!--line_discount_update_36790--></span>
      </div>
    </div>
  </div>
  <div class="ut2-pb__product-brand-name">
    <a href="https://medsgo.ph/prescription-medicines/erectile-dysfunction/?features_hash=3-16903"><span><em>Erecfil</em></span></a>
  </div>
  <div class="cm-reload-36790 stock-wrap" id="product_amount_update_36790">
    <input type="hidden" name="appearance[show_product_amount]" value="1">
    <div class="ty-control-group product-list-field">
      <span class="ty-qty-out-of-stock ty-control-group__item" id="out_of_stock_info_36790"><i class="ut2-icon-highlight_off"></i>Out of stock</span>
    </div>
    <!--product_amount_update_36790-->
  </div>
  <div class="ut2-pb__option">
    <div class="cm-reload-36790 js-product-options-36790" id="product_options_update_36790">
      <input type="hidden" name="appearance[show_product_options]" value="1">
      <input type="hidden" name="appearance[force_show_add_to_cart_button]" value="Y">
      <!-- Inline script moved to the bottom of the page -->
      <div id="features_36790_AOC">
        <div class="cm-picker-product-variation-features ty-product-options">
          <div class="ty-control-group ty-product-options__item clearfix" ab-data-info="f_id_17">
            <div class="ut2-vopt__wrap">
              <label class="ty-control-group__label ty-product-options__item-label">Dosage Strength:</label>
              <bdi>
                <div class="ty-product-option-container">
                  <div class="ty-product-option-child">
                    <select class=" cm-history cm-ajax-force" data-ca-target-id="ut2_pb__sticky_add_to_cart,product_detail_page">
                      <option disabled="">100mg</option>
                    </select>
                  </div>
                </div>
              </bdi>
            </div>
          </div>
          <div class="ty-control-group ty-product-options__item clearfix" ab-data-info="f_id_16">
            <div class="ut2-vopt__wrap">
              <label class="ty-control-group__label ty-product-options__item-label">Drug Packaging:</label>
              <bdi>
                <div class="ty-product-option-container">
                  <div class="ty-product-option-child">
                    <select class=" cm-history cm-ajax-force" data-ca-target-id="ut2_pb__sticky_add_to_cart,product_detail_page">
                      <option disabled="">Film-Coated Tablet 1's</option>
                      <option disabled="">Film-Coated Tablet 8's</option>
                    </select>
                  </div>
                </div>
              </bdi>
            </div>
          </div>
        </div>
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      <input type="hidden" name="additional_info[get_discounts]" value="1">
      <input type="hidden" name="additional_info[get_features]" value="">
      <input type="hidden" name="additional_info[get_extra]" value="">
      <input type="hidden" name="additional_info[get_taxed_prices]" value="1">
      <input type="hidden" name="additional_info[get_for_one_product]" value="1">
      <input type="hidden" name="additional_info[detailed_params]" value="1">
      <input type="hidden" name="additional_info[features_display_on]" value="C">
      <input type="hidden" name="additional_info[get_active_options]" value="">
      <input type="hidden" name="additional_info[get_only_selectable_options]" value="">
      <input type="hidden" name="additional_info[get_variation_features_variants]" value="1">
      <input type="hidden" name="additional_info[get_warehouse_amount]" value="">
      <input type="hidden" name="additional_info[get_warehouse_amount_by_destination]" value="1">
      <input type="hidden" name="additional_info[get_warehouse_total_amount]" value="">
      <input type="hidden" name="additional_info[get_detailed_warehouses_amounts]" value="">
      <input type="hidden" name="additional_info[get_variation_info]" value="1">
      <input type="hidden" name="additional_info[get_variation_name]" value="1">
      <input type="hidden" name="additional_info[get_product_type]" value="">
      <input type="hidden" name="additional_info[get_vendor_products]" value="">
      <input type="hidden" name="additional_info[get_vendor_product_ids]" value="">
      <input type="hidden" name="additional_info[runtime_company_id]" value="0">
      <!-- Inline script moved to the bottom of the page -->
      <!--product_options_update_36790-->
    </div>
  </div>
  <div class="ut2-pb__advanced-option clearfix">
    <div class="cm-reload-36790" id="advanced_options_update_36790">
      <input type="hidden" name="appearance[dont_show_points]" value="1">
      <!--advanced_options_update_36790-->
    </div>
  </div>
  <div class="ut2-pb__button ty-product-block__button">
    <div class="ut2-qty__wrap ">
      <div class="cm-reload-36790" id="qty_update_36790">
        <input type="hidden" name="appearance[show_qty]" value="">
        <input type="hidden" name="appearance[capture_options_vs_qty]" value="">
        <input type="hidden" name="product_data[36790][amount]" value="1">
        <!--qty_update_36790-->
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    </div>
    <div class="cm-reload-36790 " id="add_to_cart_update_36790">
      <input type="hidden" name="appearance[show_add_to_cart]" value="1">
      <input type="hidden" name="appearance[show_list_buttons]" value="1">
      <input type="hidden" name="appearance[but_role]" value="big">
      <input type="hidden" name="appearance[quick_view]" value="">
      <span class="hidden" id="cp_ga_product_details_data_36790" data-cpga-cm="Erectile Dysfunction" data-cpga-prodname="Erecfil-100 Sildenafil 100mg Film-Coated Tablet 1's" data-cpga-brand="Erecfil" data-cpga-price="0.00000000" data-cpga-variant=""
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      <input type="hidden" name="product_data[36790][cp_obj_prefix]" value="">
      <a class="
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      <a class="
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            <i class="ut2-icon-addchart"></i>            Compare        </a>
      <!--add_to_cart_update_36790-->
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  <div data-ca-warehouses-stock-availability-product-id="36790" id="warehouses_stock_availability_36790">
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</form>

Name: new_thread_login_form_popup_formPOST https://medsgo.ph/

<form name="new_thread_login_form_popup_form" action="https://medsgo.ph/" method="post" class="cm-ajax cm-ajax-full-render cm-processed-form">
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  <input type="hidden" name="login_block_id" value="new_thread_login_form_popup">
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    <label for="psw_new_thread_login_form_popup"
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    <input type="password" id="psw_new_thread_login_form_popup" name="password" size="30" value="" class="ty-login__input" maxlength="32">
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  <div class="ty-login-reglink ty-center">
    <a class="ty-login-reglink__a" href="https://medsgo.ph/profiles-add/" rel="nofollow">Register for a new account</a>
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    <input type="hidden" name="redirect_url"
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  <div class="buttons-container clearfix">
    <div class="ty-login__remember-me">
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    </div>
    <button class="ty-btn__login ty-btn__secondary ty-btn" type="submit" name="dispatch[auth.login]"><span><bdi>Sign in</bdi></span></button>
  </div>
  <input type="hidden" name="security_hash" class="cm-no-hide-input" value="7222536b9a8d8f09d734d82459d32530">
</form>

Name: product_form_412000scr_412_64b6cf660eac30008480POST https://medsgo.ph/

<form action="https://medsgo.ph/" method="post" name="product_form_412000scr_412_64b6cf660eac30008480" enctype="multipart/form-data" class="cm-disable-empty-files cm-ajax cm-ajax-full-render cm-ajax-status-middle cm-processed-form">
  <input type="hidden" name="result_ids" value="cart_status*,wish_list*,checkout*,account_info*,abt__ut2_wishlist_count">
  <input type="hidden" name="redirect_url" value="https://medsgo.ph/prescription-medicines/erectile-dysfunction/erecfil-100-sildenafil-100mg-film-coated-tablet-8s-clone/">
  <input type="hidden" name="product_data[scr_412_64b6cf660eac30008480][product_id]" value="8480">
  <bdi> <span class="hidden" id="cp_ga_product_data_412000scr_412_64b6cf660eac30008480" data-cpga-cm="Erectile Dysfunction" data-cpga-prodname="Spiagra-100 Sildenafil 100mg Film-Coated Tablet 10's" data-cpga-brand="Spiagra-100" data-cpga-price="0"
      data-cpga-variant="" data-cpga-pos="1" data-cpga-list="" data-cpga-pid="8480" data-cpga-href="https://medsgo.ph/prescription-medicines/erectile-dysfunction/spiagra-100-sildenafil-100mg-film-coated-tablet-10s/">
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    <input type="hidden" name="product_data[scr_412_64b6cf660eac30008480][cp_obj_prefix]" value="412000">
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Home/Prescription Medicines/Erectile Dysfunction/Erecfil-100 Sildenafil 100mg
Film-Coated Tablet 1's


ERECFIL-100 SILDENAFIL 100MG FILM-COATED TABLET 1'S

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Erecfil-100 Sildenafil 100mg Film-Coated Tablet 1's




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CODE: RXDRUG-DRP-3155-1pc
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Erecfil
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Dosage Strength:
100mg
Drug Packaging:
Film-Coated Tablet 1's Film-Coated Tablet 8's

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FEATURES

Brand
Erecfil
Full Details
Dosage Strength
100mg
Drug Ingredients
 * Sildenafil

Drug Packaging
Film-Coated Tablet 1's
Generic Name
Sildenafil
Dosage Form
Film-Coated Tablet
Registration Number
DRP-3155
Drug Classification
Prescription Drug (RX)
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DESCRIPTION


FORMULATION:

Each film-coated tablet contains:

Sildenafil Citrate 100 mg

 


DRUG CATEGORY:

Vasodilator Agent, Phosphodiestrase Inhibitor.

 


PRODUCT DESCRIPTION:

Blue colored diamond shaped biconvex breakline on one side plain on other side
film-coated tablet.

 


PHARMACODYNAMIC PROPERTIES

Pharmacotherapeutic group: Urologicals; Drugs used in erectile dysfunction.

Mechanism of action

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.

The physiological mechanism responsible for erection of the penis involves the
release of nitric oxide (NO) in the corpus cavemosum during sexual stimulation.
Nitric oxide then activates the enzyme guanylate cyclase, which results in
increased levels of cyclic guanosine monophosphate (cGMP), producing smooth
muscle relaxation in the corpus cavemosum and allowing inflow of blood.

Sildenafil is a potent and selective inhibitor of cGMP specific
phosphodiesterase type 5 (PDE5) in the corpus cavemosum, where PDE5 is
responsible for degradation of cGMP. Sildenafil has a peripheral site of action
on erections. Sildenafil has no direct relaxant effect on isolated human corpus
cavemosum but potently enhances the relaxant effect of NO on this tissue. When
the NO/cGMP pathway isactivated, as occurs with sexual stimulation, inhibition
of PDE5 by Sildenafil results in increased corpus cavemosum levels of cGMP.
Therefore, sexual stimulation is required in order for Sildenafil to produce its
intended beneficial pharmacological effects. — . _

Pharmacodynamic Effects

Studies in vitro have shown that Sildenafil is selective for PDE5, which is
involved in the erection process. Its effect is more potent on PDE5 than on
other known phosphodiesterases. There is a 10-fold selectivity over PDE6 which
is involved in the phototransduction pathway in the retina. At maximum
recommended doses, there is an 80-fold selectivity over PDE1, and over700-fold
over PDE 2,3,4,7,8,9,10, and 11. In particular, Sildenafil has greater than
4,000-fold selectivity for PDE5 over PDE3, the cAMP-specific phosphodiesterase
isoform involved in the control of cardiac contractility.

Clinical efficacy and safety

Two clinical studies were specifically designed to assess the time window after
dosing during which Sildenafil could produce an erection in response to sexual
stimulation. In a penile plethysmography (RigiScan) study of fasted patients,
the median time to onset for those who obtained erections of 60% rigidity
(sufficient for sexual intercourse) was 25 minutes (range 12-37 minutes) on
Sildenafil. In a separate RigiScan study, Sildenafil was still able to produce
an erection in response to sexual stimulation 4-5 hours post-dose.

Sildenafil causes mild and transient decreases in blood pressure which, in the
majority of cases, do not translate into clinical effects. The mean maximum
decreases in supine systolic blood pressure following 100 mg oral dosing of
Siidenafii was 8.4 mmHg. The corresponding change in supine diastolic blood
pressure was 5.5 mmHg. These decreases in biood pressure are consistent with the
vasodilatory effects of Sildenafil, probably due to increased cGMP levels in
vascular smooth muscle. Single oral doses of Sildenafil up to 100 mg in healthy
volunteers produced no clinically relevant effects on ECG.

tn a studyofthe tremodynamic effects of asingieorat 100
rngxiose-ofSildenaftHnTApatients with sevefeeoronafyartefy-diseaseTCA&/(>70%
stenosis-of at feast one coronary artery), the mean resting systolic and
diastolic blood pressures decreased by 7% and 6% respectively compared to
baseline. Mean pulmonary systolic blood pressure decreased by 9%. Sildenafil
showed no effect on cardiac output, and did not impair blood flow through the
stenosed coronary arteries.

Adouble-blind, placebo-controlled exercise stress trial evaluated 144 patients
with erectile dysfunction and chronic stable angina who regularly received
anti-anginal medicinal products (except nitrates). The results demonstrated no
clinically relevant differences between Sildenafil and placebo in time to
limiting angina.

Mild and transient differences in color discrimination (blue/green) were
detected in some subjects using the Farnsworth-Munsell 100 hue test at 1 hour
following a 100 mg dose, with no effects evident after 2 hours post-dose. The
postulated mechanism for this change in color discrimination is related to
inhibition of PDE6, which is involved in the phototransduction cascade of the
retina. Siidenafii has no effect on visual acuity or contrast sensitivity. In a
small size placebo-controlled study of patients with documented early
age-related macular degeneration (n=9), Sildenafil (single dose, 100 mg)
demonstrated no significant changes in visual tests conducted (visual acuity,
Amsler grid, color discrimination simulated traffic light, Humphrey perimeter,
and photostress).

There was no effect on sperm motility or morphology after single 100 mg oral
doses of Sildenafil in healthy volunteers.

Further information on clinical trials

In clinical trials Sildenafil was administered to more than 8000 patients aged
19-87. The following patient groups were represented: elderly (19.9%), patients
with hypertension (30.9%), diabetes mellitus (20.3%), ischaemic heart disease
(5.8%), hyperlipidaemia (19.8%), spinal cord injury (0.6%), depression (5.2%),
transurethral resection of the prostate (3.7%), radical prostatectomy (3.3%).
The following groups were not well represented or excluded from clinical trials:
patients with pelvic surgery, patients post-radiotherapy, patients with severe
renal or hepatic impairment and patients with certain cardiovascuiarconditions.

In fixed dose studies, the proportions of patients reporting that treatment
improved their erections were 62% (25 mg), 74% (50 mg) and 82% (100 mgj compared
to 25% on placebo. In controlled clinical trials, the discontinuation rate due
to Sildenafil was low and similar to placebo.

Across all trials, the proportion of patients reporting improvement on
Sildenafil were as follows: psychogenic erectile dysfunction (84%), mixed
erectile dysfunction (77%), organic erectile dysfunction (68%), elderly (67%),
diabetes mellitus (59%), ischaemic heart disease (69%), hypertension (68%), TURP
(61%), radical prostatectomy (43%), spinal cord injury (83%), depression (75%).
The safety and efficacy of Sildenafil was maintained in long term studies.

Pediatric population

The European Medicines Agency has waived the obligation to submit the results of
studies with Sildenafil in all subsets of the paediatric population for the
treatment of erectile dysfunction.

 


PHARMACOKINETIC PROPERTIES

Absorption

Sildenafil is rapidly absorbed. Maximum observed plasma concentrations are
reached within 30 to 120 minutes (median 60 minutes) of oral dosing in the
fasted state. The mean absolute oral bioavailability is 41 % (range 25-63%).
After oral dosing of Siidenafii, AUC and Cmax increase in proportion with dose
over the recommended dose range (25-100 mg).

When Sildenafil is taken with food, the rate of absorption is reduced with a
mean delay in T^ of 60 minutes and a mean reduction in of 29%.

Distribution

The mean steady state volume of distribution (Vd) for Sildenafil is 105L,
indicating distribution into the tissues. After a single oral dose of 100 mg,
the mean maximum total plasma concentration of Sildenafil is approximately 440
ng/mL (CV 40%). Since Sildenafil (and its major circulating N-desmethyl
metabolite) is 96% bound to plasma proteins, this results in the mean maximum
free plasma concentration for Sildenafil of 18 ng/mL (38 nM). Protein binding is
independent of total drug concentrations. . . .

In healthy volunteers receiving Sildenafil (100 mg single dose), less than
0.0002% (average 188 ng) of the administered dose was present in ejaculate 90
minutes after dosing.

Biotransformation

Sildenafil is cleared predominantly by the CYP3A4 (major route) and CYP2C9
(minor route) hepatic microsomal isoenzymes. The major circulating metabolite
results from N-demethylation of Sildenafil. This metabolite has a
phosphodiesterase selectivity profile similar to Sildenafil and an in
vitro potency for PDE5 approximately 50% that of the parent drug. Plasma
concentrations of this metabolite are approximately 40% of those seen for
Sildenafil. The N-desmethyl metabolite is further metabolized, with a terminal
half life of approximately 4 h.

Elimination

The total body clearance of Sildenafil is 41 L/h with a resultant terminal phase
half life of 3-5 h. After either oral or intravenous administration, Sildenafil
is excreted as metabolites predominantly in the feces (approximately 80% of
administered oral dose) and to a lesser extent in the urine (approximately 13%
of administered oral dose).

 


INDICATION:

Forthe treatment of erectile dysfunction.

 


DOSAGE AND ADMINISTRATION:

For treatment of erectile dysfunction:

Adults up to 65 years of age - 50 mg as a single dose not more than once a day,
1 hour before sexual intercourse.

Adults 65 years of age and older - 25 mg as a single dose not more than once a
day, 1 hour before sexual intercourse.

Administration in Hepatic Impairment:

In the management of erectile dysfunction, an initial dose of 25 mg of
Sildenafil is recommended by licensed drug information in patients with hepatic
impairment.

Administration in Hepatic Impairment:

In the management of erectile dysfunction, an initial dose of 25 mg of
Sildenafil is recommended by licensed drug information in patients with severe
renal impairment (creatinine clearance less than 30 ml/minute). If you are
taking protease inhibitors, such as for the treatment of HIV, your doctor may
recommend a 25 mg dose and may limit you to a maximum single dose of 25 mg in
48-hour period.

Fortreatment of pulmonary arterial hypertension:

Adults - 20 mg three times per day.

Children -use and dose must be determined by your doctor. Oras prescribed by the
physician.

 


CONTRAINDICATIONS:

Consistent with its known effects on the nitric oxide cGMP pathway, Sildenafil
citrate was shown to potentiate the hypotensive effects of nitrates, and its
administration to patients who are using organic nitrates either regularly
and/or intermittently in any form is therefore contraindicated.

Sildenafil citrate is contraindicated in patients with a known hypersensitivity
to any component of the tablet.

 


WARNINGS AND PRECAUTIONS:

Sildenafil has not been studied with other medicines used for treatment of
erectile dysfunction. Presently, using them together is not recommended. If too
much is used, the chance of side effects is increased. If you experience a
prolonged or painful erection for 4 hours or more, contact your doctor
immediately. This condition may require prompt medical treatment to prevent
tissue damage of the penis and possible permanent impotence. This medicine does
not protect you against sexually transmitted diseases. If you experience sudden
loss of vision in one or both eyes, stop using Sildenafil and contact your
doctor immediately.

Pregnancy:

Sildenafil is not indicated for use in women. Sildenafil has not been studied in
pregnant women. However, Sildenafil has not been shown to cause birth defects or
other problems in animal studies.

Breastfeeding:

It is not known whether Sildenafil passes into breast milk. Sildenafil is not
indicated for use in women for erectile dysfunction. Mothers who are taking this
medicine for pulmonary arterial hypertension and who wish to breastfeed should
discuss this with their doctor.

Older adults:

Elderly people are especially sensitive to the effects of Sildenafil, which may
increase their chance of having side effects. Patients 65 years of age and older
who are taking this medicine forerectile dysfunction are started on a low dose,
25 mg, of Sildenafil.

 


ADVERSE DRUG REACTIONS:

Abnormal vision, including blurred vision, seeing shades of colors differently
than before, or sensitivity to light; bladder pain; burning, crawling, itching,
numbness, prickling, “pins and needles”, or tingling feelings; burning feeling
in chest or stomach; cloudy or bloody urine; dizziness; increased frequency of
urination; ingestion; indigestion; pain on urination; upset stomach; tenderness
in stomach area.

 


DRUG INTERACTIONS:

Sildenafil or other phosphodiesterase type-5 inhibitors may potentiate the
hypotensive effects of organic nitrates, and are therefore contraindicated in
patients receiving such drugs. Sildenafil may also enhance the hypotensive
effect of Nicorandil and use of the two drugs together should be avoided.
Symptomatic hypotension may also occur when phosphodiesterase type-5 inhibitors
are given with alpha blockers. Generally the patient should be established on
alpha blocker therapy before the phosphodiesterase type-5 inhibitor is started
at a low dose and adjusted according to response; minimum dosage intervals have
also been recommended in some cases. Drugs that inhibit the cytochrome P450
isoenzyme CYP3A4, such as Cimetidine, Delavirdine, Erythromycin, Itraconazole,
Ketoconazole, and HIV-protease inhibitors, may reduce the clearance of
phosphodiesterase type-5 inhibitors, necessitating a reduction in dosage.
Furthermore, plasma concentrations of phosphodiesterase type-5 inhibitors are
significantly increased by Ritonavir, requiring even greater dosage reduction,
and such combinations should not be given unless absolutely essential.
Grapefruit juice should be avoided with Sildenafil or other phospodiesterase
type-5 inhibitors as it may increase their plasma concentrations.

Inducers of CYP3A4, such as Rifampicin, are likely to decrease plasma
concentrations of phosphodiesterase type-5 inhibitors. Specific dosage
recommendations have been made forthe use of phosphodiesterase Type-5 inhibitors
with many ofthese drugs.

Single doses of antacid (magnesium hydroxide/aluminum hydroxide) did not affect
the bioavailability of Sildenafil citrate. Sildenafil citrate (50 mg) did not
potentiate the increase in bleeding time caused by aspirin (150 mg).

Sildenafil citrate (50 mg) did not potentiate the hypotensive effect of alcohol
in healthy volunteers with mean maximum blood alcohol levels of 0.08%.
Sildenafil (100 mg) did not affect the steady state pharmacokinetics of the HIV
protease inhibitors, Saquinavir and Ritonavir, both of which are CYP3A4
substrates.

Alpha-blockers (medicine for high blood pressure - Sildenafil when taken
together with an alpha-blocker medicine may cause very low blood pressure.
Cimetidine, Erythromycin, Itraconazole, Ketoconazole and Mibefradil - These
medicines may increase the unwanted effects of Sildenafil, unless lower starting
doses of Sildenafil are used.

Erectile dysfunction medicines - These medicines should not be used at the same
time as Sildenafil because the safety or using these medicines in combination
has not been proven. Nitrates, such as Nitroglycerin - Sildenafil increases the
lowering of blood pressure by nitrates too much and their use together is not
recommended.

 


OVERDOSE AND TREATMENT:  

In studies with healthy volunteers of single doses up to 800 mg, adverse events
were similar to those seen at lower doses but incidence rates and severities
were 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 it is not eliminated in the urine.

 


CAUTION:

Foods, Drugs, Devices, and Cosmetics Act prohibits dispensing without
prescription.

For suspected adverse drug reaction, report to the FDA: www.fda.gov.ph.

Seek medical attention immediately at the first sign of any adverse drug
reaction.

 


STORAGE CONDITION;

Store at temperatures not exceeding 30°C.

 

KEEP ALL MEDICINES OUT OF REACH OF CHILDREN.

 


AVAILABILITY:

Alu//Clear PVC Blister Packx 4’s (Box of 4’s & 8's)

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Contact us
 * Mandaluyong, Soho Central, 748 Shaw Blvd
 * +63(998)567-6337 (the call is free)
 * +63(906)084-8874
 * Mon-Sun 9.00 - 18.00
 * contact@medsgo.ph
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