Sildenafil Citrate (Revatio)

Trade Name : Revatio

Pfizer Laboratories Div Pfizer Inc

POWDER, FOR SUSPENSION

Strength 10 mg/mL

SILDENAFIL CITRATE Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Sildenafil Citrate (Revatio) which is also known as Revatio and Manufactured by Pfizer Laboratories Div Pfizer Inc. It is available in strength of 10 mg/mL per ml. Read more

Sildenafil Citrate (Revatio) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • No data
  • REVATIO is indicated for the treatment of pulmonary arterial hypertension (WHO Group I) in adults to improve exercise ability and delay clinical worsening. The delay in clinical worsening was demonstrated when REVATIO was added to background epoprostenol therapy .
  • Studies establishing effectiveness were short-term (12 to 16 weeks), and included predominately patients with New York Heart Association (NYHA) Functional Class IIu2013III symptoms and idiopathic etiology (71%) or associated with connective tissue disease (CTD) (25%).
  • REVATIO is a phosphodiesterase-5 (PDE-5) inhibitor indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group I) in adults to improve exercise ability and delay clinical worsening. Studies establishing effectiveness were short-term (12 to 16 weeks), and included predominately patients with NYHA Functional Class IIu2013III symptoms. Etiologies were idiopathic (71%) or associated with connective tissue disease (25%). ()
  • Limitation of Use
  • No data
  • Tablet and oral suspension: 5 mg or 20 mg three times a day, 4u20136 hours apart ()
  • Injection: 2.5 mg or 10 mg three times a day administered as an intravenous bolus injection ()
  • No data
  • Tablets
  • Injection
  • For Oral Suspension
  • REVATIO is contraindicated in patients with:
  • Use with organic nitrates or riociguat ()
  • History of hypersensitivity reaction to sildenafil or any component of the tablet, injection, or oral suspension ()
  • No data
  • Increased mortality with increasing doses in pediatric patients. Not recommended for use in pediatric patients. ()
  • Vasodilation effects may be more common in patients with hypotension or on antihypertensive therapy. ()
  • Use in pulmonary veno-occlusive disease may cause pulmonary edema and is not recommended. ()
  • Hearing or visual impairment: Seek medical attention if sudden decrease or loss of vision or hearing occurs. (, )
  • Pulmonary hypertension secondary to sickle cell disease: REVATIO may cause serious vaso-occlusive crises. ()
  • The following serious adverse events are discussed elsewhere in the labeling:
  • Most common adverse reactions greater than or equal to 3% and more frequent than placebo were epistaxis, headache, dyspepsia, flushing, insomnia, erythema, dyspnea, and rhinitis. (, )
  • To report SUSPECTED ADVERSE REACTIONS, contact Pfizer at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • No data
  • Concomitant alpha-blockers or amlodipine: Note additive blood pressure lowering effects. ()
  • Use with ritonavir and other potent CYP3A inhibitors: Not recommended. (, )
  • Concomitant PDE-5 inhibitors: Avoid use with Viagra or other PDE-5 inhibitors. ()
  • No data
  • In studies with healthy volunteers of single doses up to 800 mg, adverse events were similar to those seen at lower doses but 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.
  • REVATIO, phosphodiesterase-5 (PDE-5) inhibitor, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type-5 (PDE-5). Sildenafil is also marketed as VIAGRA for erectile dysfunction.
  • Sildenafil citrate is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1-pyrazolo [4,3-] pyrimidin-5-yl)-4-ethoxyphenyl] sulfonyl]-4-methylpiperazine citrate and has the following structural formula:
  • Sildenafil citrate is a white to off-white crystalline powder with a solubility of 3.5 mg/mL in water and a molecular weight of 666.7.
  • REVATIO (sildenafil) Tablets: REVATIO is formulated as white, film-coated round tablets for oral administration. Each tablet contains sildenafil citrate equivalent to 20 mg of sildenafil. In addition to the active ingredient, sildenafil citrate, each tablet contains the following inactive ingredients: microcrystalline cellulose, anhydrous dibasic calcium phosphate, croscarmellose sodium, magnesium stearate, hypromellose, titanium dioxide, lactose monohydrate, and triacetin.
  • REVATIO (sildenafil) Injection: REVATIO is supplied as a clear, colorless, sterile, ready to use solution in a single-use vial containing 10 mg/12.5 mL of sildenafil. Each mL of solution contains 1.124 mg sildenafil citrate (equivalent to 0.8 mg sildenafil), 50.5 mg dextrose and water for injection.
  • REVATIO (sildenafil) for Oral Suspension: REVATIO is supplied as white to off-white powders containing 1.57 g of sildenafil citrate (equivalent to1.12 g sildenafil) in an amber glass bottle intended for constitution. Following constitution with 90 mL water, the volume of the oral suspension is 112 mL and the oral suspension contains 10 mg/mL sildenafil. The inactive ingredients include sorbitol, citric acid anhydrous, sucralose, sodium citrate dihydrate, xanthan gum, titanium dioxide, sodium benzoate, colloidal silicon dioxide anhydrous and grape flavor. In addition to the bottle, a press-in bottle adapter and an oral dosing syringe (with 0.5 mL and 2 mL dose markings) are provided.
  • No data
  • Sildenafil was not carcinogenic when administered to rats for up to 24 months at 60 mg/kg/day, a dose resulting in total systemic exposure (AUC) to unbound sildenafil and its major metabolite 33- and 37- times, for male and female rats respectively, the human exposure at the RHD of 20 mg three times a day. Sildenafil was not carcinogenic when administered to male and female mice for up to 21 and 18 months, respectively, at doses up to a maximally tolerated level of 10 mg/kg/day, a dose equivalent to the RHD on a mg/mbasis.
  • Sildenafil was negative in bacterial and Chinese hamster ovary cell assays to detect mutagenicity, and human lymphocytes and mouse micronucleus assays to detect clastogenicity.
  • There was no impairment of fertility in male or female rats given up to 60 mg sildenafil/kg/day, a dose producing a total systemic exposure (AUC) to unbound sildenafil and its major metabolite of 19- and 38- times for males and females, respectively, the human exposure at the RHD of 20 mg three times a day.
  • Studies of Adults with Pulmonary Arterial Hypertension
  • REVATIO tablets are supplied as white, film-coated, round tablets containing sildenafil citrate equivalent to the nominally indicated amount of sildenafil as follows:
  • See .
  • This product's label may have been updated. For current full prescribing information, please visit www.pfizer.com
  • LAB-0313-19.0
  • REVATIOu00ae
  • REVATIOu00ae
  • Read this Patient Information before you start taking REVATIO and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or treatment. If you have any questions about REVATIO, ask your doctor or pharmacist.
  • What is the most important information I should know about REVATIO?
  • Never take REVATIO with any nitrate or guanylate cyclase stimulator medicines. Your blood pressure could drop quickly to an unsafe level.
  • Nitrate medicines include:
  • Guanylate cyclase stimulators include:
  • Ask your doctor or pharmacist if you are not sure if you are taking a nitrate or a guanylate cyclase stimulator medicine.
  • What is REVATIO?
  • REVATIO is a prescription medicine used in adults to treat pulmonary arterial hypertension (PAH). With PAH, the blood pressure in your lungs is too high. Your heart has to work hard to pump blood into your lungs.
  • REVATIO improves the ability to exercise and can slow down worsening changes in your physical condition.
  • REVATIO contains the same medicine as VIAGRAu00ae (sildenafil), which is used to treat erectile dysfunction (impotence). Do not take REVATIO with VIAGRA or other PDE-5 inhibitors.
  • Who should not take REVATIO?
  • Do not take REVATIO if you:
  • What should I tell my doctor before taking REVATIO?
  • Tell your doctor about all of your medical conditions, including if you
  • Tell your doctor about all of the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal products.
  • Especially tell your doctor if you take
  • Know the medicines you take. Keep a list of your medicines and show it to your doctor and pharmacist when you get a new medicine.
  • How should I take REVATIO?
  • REVATIO may be prescribed to you as
  • What are the possible side effects of REVATIO?
  • The most common side effects with REVATIO include:
  • Nosebleed, headache, upset stomach, getting red or hot in the face (flushing), trouble sleeping, as well as fever, erection increased, respiratory infection, nausea, vomiting, bronchitis, pharyngitis, runny nose, and pneumonia in children.
  • Tell your doctor if you have any side effect that bothers you or doesn't go away.
  • These are not all the possible side effects of REVATIO. For more information, ask your doctor or pharmacist.
  • Call your doctor for medical advice about side effects. You may report side effects to FDA at 1800-FDA-1088.
  • How should I store REVATIO?
  • General information about REVATIO
  • Medicines are sometimes prescribed for purposes that are not in the patient leaflet. Do not use REVATIO for a condition for which it was not prescribed. Do not give REVATIO to other people, even if they have the same symptoms you have. It could harm them.
  • This patient leaflet summarizes the most important information about REVATIO. If you would like more information about REVATIO talk with your doctor. You can ask your doctor or pharmacist for information about REVATIO that is written for health professionals.
  • For more information go to www.REVATIO.com or call 1-800-879-3477.
  • What are the ingredients in REVATIO?
  • REVATIO tablets
  • Active ingredients:
  • Inactive ingredients:
  • REVATIO for oral suspension
  • Active ingredients:
  • Inactive ingredients:
  • This product's label may have been updated. For current full prescribing information, please visit www.pfizer.com
  • This Patient Information has been approved by the U.S. Food and Drug Administration
  • LAB-0335-12.0January 2019
  • Instructions for Use
  • REVATIOu00ae
  • Read this Instructions for Use for REVATIO oral suspension before you start taking and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or your treatment.
  • Important information:
  • Supplies you will need to take REVATIO oral suspension:
  • Administer REVATIO oral suspension using the oral syringe supplied with each pack. Refer to the patient instructions for use for more detailed instructions for use. Discard any unused suspension after the expiration date written on the bottle.
  • How should I store REVATIO?
  • This Instruction for Use has been approved by the U.S. Food and Drug Administration.
  • This product's label may have been updated. For current full prescribing information, please visit www.pfizer.com
  • LAB-0575-3.0January 2014
  • Issued Jan/2014
  • Pfizer
  • NDC 0069-4190-68
  • Revatio
  • 20 mg*
  • 90 Tablets n n
  • NDC 0069-0338-01n n
  • Sterile Single-use Vial
  • Revatio
  • 10 mg/12.5 mL
  • Sterile Single-use Vial,Discard Unused Portion
  • Pfizer Injectables
  • NDC 0069-0338-01n n
  • Sterile Single-use Vial
  • Revatio
  • 10 mg/12.5 mL
  • For Intravenous UseSterile Single-use Vial,Discard Unused Portion
  • Pfizer Injectables
  • NDC 0069-0336-21
  • Revation- (sildenafil) for oral suspension
  • 10 mg/mL
  • Shake Well Before Each UseFor Oral Use Only
  • Pfizer
  • NDC 0069-0336-21
  • Revation- (sildenafil) for oral suspension
  • 10 mg/mL
  • For Oral Use OnlyShake Well Before Each Use
  • 112 mL following Constitution
  • Grape Flavored
  • Pfizer
  • Rx only

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