Alprostadil (Caverject Impulse)

Trade Name : Caverject Impulse

Pharmacia and Upjohn Company LLC

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

Strength 10 ug/.5mL

ALPROSTADIL Genitourinary Arterial Vasodilation [PE],Prostaglandin Analog [EPC],Prostaglandin E1 Agonist [EPC],Prostaglandin Receptor Agonists [MoA],Prostaglandins [CS],Venous Vasodilation [PE]

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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 Alprostadil (Caverject Impulse) which is also known as Caverject Impulse and Manufactured by Pharmacia and Upjohn Company LLC. It is available in strength of 10 ug/.5mL per ml. Read more

Alprostadil (Caverject Impulse) 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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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
  • CAVERJECT IMPULSE is a prostaglandin E1 agonist indicated
  • For the treatment of erectile dysfunction ()
  • As an adjunct to other diagnostic tests in the diagnosis of erectile dysfunction ().
  • No data
  • Determine the most suitable dose and formulation of CAVERJECT to use ()
  • Administer first intracavernosal injections in the physician's office and titrate the dose for each patient to the lowest effective dose ()
  • Dosage for erectile dysfunction ():n
  • Follow dose titration procedures for each type of erectile dysfunction and determine the maintenance dosage for erectile dysfunction for patient home use in the physician's office ()
  • The recommended frequency of injection is no more than 3 times weekly, with at least 24 hours between each dose ()
  • While on self-injection treatment, the patient should visit the prescribing physician's office every 3 months to assess the efficacy and safety of the therapy ()
  • Instruct the patient on proper use and assess that they are well trained in the self-injection technique prior to initiation of at-home use ()
  • To diagnose erectile dysfunction (pharmacologic testing), inject CAVERJECT IMPULSE intracavernosally and monitor patients for the occurrence of an erection ()
  • Follow procedure for CAVERJECT IMPULSE syringe preparation ()
  • Caverject Impulse (alprostadil) for injection contains sterile, freeze-dried alprostadil for reconstitution and sterile bacteriostatic water in a prefilled dual chamber glass cartridge. It is available in 10 mcg and 20 mcg strengths.
  • For injection: 10 mcg or 20 mcg freeze-dried powder for reconstitution in a dual-chamber syringe ()
  • CAVERJECT IMPULSE should not be used:
  • Known hypersensitivity to the drug ()
  • Men who have conditions that predispose them to priapism, such as sickle cell anemia or sickle cell trait, multiple myeloma, or leukemia ()
  • Treatment of erectile dysfunction in men with fibrotic conditions of the penis, such as anatomical deformation, angulation, cavernosal fibrosis, or Peyronie's disease ()
  • Men with penile implants ()
  • No data
  • Prolonged erection and priapism
  • Penile fibrosis
  • Hypotension
  • Injection site bleeding
  • Cardiovascular risk related to underlying medical conditions
  • Risks of use in combination with other vasoactive medications injected intracavernosally
  • Risk of needle breakage
  • Benzyl alcohol
  • C. Counseling of patients about the protective measures necessary to guard against sexually transmitted disease including the Human Immunodeficiency Virus (HIV) is advised. ()
  • The following are discussed in more detail in other sections of the labeling:
  • Most common (u226510%) adverse reactions: penile pain ()n n n
  • The potential for pharmacokinetic drug-drug interactions between alprostadil and other agents administered orally or intracavernosally has not been formally studied .
  • No data
  • Overdosage was not observed in clinical trials with CAVERJECT IMPULSE. If intracavernous overdose of CAVERJECT IMPULSE occurs, the patient should be under medical supervision until any systemic effects have resolved and/or until penile detumescence has occurred. Treatment of any systemic symptoms (e.g., hypotension) would be appropriate.
  • CAVERJECT IMPULSE contains alprostadil a synthetic form of prostaglandin E (PGE) and is designated chemically as (11u03b1,13E,15S)-11,15-dihydroxy-9-oxoprost-13-en-1-oic acid. The molecular weight is 354.49.
  • Alprostadil is a white to off-white crystalline powder with a melting point between 115u00b0 and 116u00b0C. Its solubility at 35u00b0C is 8000 micrograms (mcg) per 100 milliliter double distilled water.
  • The structural formula of alprostadil is represented below:
  • CAVERJECT IMPULSE is available as a disposable, single-dose, dual chamber syringe system. The system includes a glass cartridge which contains sterile, freeze-dried alprostadil in the front chamber and sterile bacteriostatic water for injection in the rear chamber. The alprostadil is reconstituted with the sterile bacteriostatic water just before injection. CAVERJECT IMPULSE is available in two strengths for intracavernosal administration:
  • 10 microgram
  • 20 microgram
  • During manufacture, the pH of the alprostadil for injection was adjusted with hydrochloric acid and/or sodium hydroxide before lyophilization.
  • No data
  • Long-term carcinogenicity studies have not been conducted. The following battery of mutagenicity assays revealed no potential for mutagenesis: bacterial mutation (Ames), alkaline elution, rat micronucleus, sister chromatid exchange, CHO/HGPRT mammalian cell forward gene mutation, and unscheduled DNA synthesis (UDS). Rat reproductive studies indicate that alprostadil at doses of up to 0.2 mg/kg/day does not adversely affect or alter rat spermatogenesis, providing a 200-fold margin of safety compared with the usual human doses.
  • The efficacy of CAVERJECT Sterile Powder was investigated in men with a diagnosis of erectile dysfunction due to psychogenic, vasculogenic, neurogenic, and/or mixed etiology in two double-blind placebo controlled studies (Study 1 and Study 2) and in one 6-month open-label study (Study 3). In clinical studies (Study 1 and Study 3), over 80% of patients experienced an erection sufficient for sexual intercourse after intracavernosal injection of CAVERJECT Sterile Powder.
  • CAVERJECT IMPULSE is supplied as a disposable, single-dose, dual chamber syringe system. The system includes a glass cartridge, which contains sterile, freeze-dried alprostadil in the front chamber and sterile bacteriostatic water for reconstitution in the rear chamber. The syringes contain either 12.8 or 25.6 mcg of alprostadil to allow delivery of a maximum of 10 or 20 mcg/0.5mL. Store the unreconstituted product at 68u00b0F to 77u00b0F (20u00b0C to 25u00b0C); excursions permitted to 59u00b0F to 86u00b0F (15u00b0C to 30u00b0C) [see USP Controlled Room Temperature].
  • When reconstituted and used as directed, the deliverable amount for the 10 mcg strength is 10 mcg/0.5 mL or an increment of 10 mcg/0.5 mL: 2.5 mcg/0.125 mL, 5 mcg/0.25 mL, or 7.5 mcg/0.375 mL of alprostadil. The deliverable amount for the 20 microgram strength is 20 mcg/0.5 mL or an increment of 20 mcg/0.5 mL: 5 mcg/ 0.125 mL, 10 mcg/0.250 mL, or 15 mcg/0.375 mL of alprostadil. The reconstituted solution should be used within 24 hours when stored between 36u201377u00b0F (2u00b0C to 25u00b0C). Do not freeze.
  • CAVERJECT IMPULSE is supplied in a carton containing 2 blister trays. Each blister tray contains one dual chamber syringe system, one needle and 2 alcohol swabs. It is available in the following strengths:
  • Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use)
  • This product's label may have been updated. For current full prescribing information, please visit www.pfizer.com
  • LAB-0007-9.0
  • CAVERJECT IMPULSE [KAV-er-jeckt] ttttttt
  • (alprostadil)for injection, for intracavernosal use
  • Read this Patient Information before you start using CAVERJECT IMPULSE and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.
  • What is CAVERJECT IMPULSE?
  • CAVERJECT IMPULSE is a prescription medicine used:
  • CAVERJECT IMPULSE is not meant for use in women or children under 18 years of age.
  • Who should not use CAVERJECT IMPULSE?
  • Do not use CAVERJECT IMPULSE if you have:
  • What should I tell my healthcare provider before using CAVERJECT IMPULSE?
  • Before you use CAVERJECT IMPULSE, tell your healthcare provider if you:
  • Tell your healthcare provider about all the medicines you take,
  • CAVERJECT IMPULSE may affect the way other medicines work, and other medicines may affect the way CAVERJECT IMPULSE works causing side effects.
  • Especially tell your healthcare provider if you take
  • Ask your healthcare provider or pharmacist for a list of these medicines, if you are not sure.
  • Know the medicines you take. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine.
  • How should I use CAVERJECT IMPULSE?
  • You should see your healthcare provider every 3 months for check-ups to be sure that CAVERJECT IMPULSE is working the right way and to change your CAVERJECT IMPULSE dose if needed.
  • What are the possible side effects of CAVERJECT IMPULSE?
  • CAVERJECT IMPULSE may cause serious side effects, including:
  • CAVERJECT IMPULSE does not protect you or your partner from getting sexually transmitted infections, including HIV-the virus that causes AIDS.
  • The most common side effects of CAVERJECT IMPULSE include:
  • Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
  • These are not all the possible side effects of CAVERJECT IMPULSE. For more information, ask your healthcare provider or pharmacist.
  • Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
  • General information about the safe and effective use of CAVERJECT IMPULSE
  • Medicines are sometimes prescribed for purposes other than those listed in a Patient Information Leaflet. Do not use CAVERJECT IMPULSE for a condition for which it was not prescribed. Do not give CAVERJECT IMPULSE to other people even if they have the same symptoms that you have. It may harm them.
  • This Patient Information summarizes the most important information about CAVERJECT IMPULSE. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about CAVERJECT IMPULSE that is written for health professionals.
  • For more information, go to www.pfizer.com or call 1-800-438-1985.
  • What are the Ingredients in CAVERJECT IMPULSE?
  • Active ingredient:
  • Inactive ingredients:
  • What are the causes of and treatments for ED?
  • There are several causes of ED. These include medications that you may be taking for other conditions, poor blood circulation in the penis, nerve damage, emotional problems, too much smoking or alcohol use, use of street drugs, and hormonal problems. Often, ED is due to more than one cause.
  • Treatments for ED include switching medications if you are taking a medication that causes erectile dysfunction, prescription medications, medical devices that produce an erection, surgical procedures to correct blood flow in the penis, penile implants, and psychological counseling.
  • You should not stop taking any prescription medications, unless told to do so by your doctor.
  • The use of other medical treatments for ED in combination with CAVERJECT is not recommended. Discuss any concerns you may have about combination treatment with your doctor.
  • Before you use CAVERJECT, your doctor must train you in how to prepare and give the injection properly.
  • Before using CAVERJECT, talk to your doctor about what to expect when using it, possible side effects, and what to do if side effects occur. Your dose has been selected for your individual needs. Do not change your dose without consulting your doctor. If you are not sure of the volume or dose to be used, talk to your doctor or pharmacist.
  • Follow these instructions exactly to properly prepare the syringe for use, and to correctly inject a sterile (germ-free) dose of CAVERJECT.
  • Supplies Needed
  • The CAVERJECT IMPULSE carton contains two (2) sealed plastic trays, with one dose of Caverject in each tray.
  • Each tray contains: (a) a , (b) a separate and (c) two . The syringe and the needle assembly are shown in Figure A (below). Please note that the is packaged as a single piece and is sealed with a paper cover on the bottom.
  • DO NOT try to assemble the syringe until you have read ALL of the instructions.
  • First-read through ALL of the instructions (Step 1 through Step 12) before trying to assemble the syringe. Then go back to Step 1 and begin to prepare the syringe for use.
  • CAVERJECT IMPULSE is available in two versions: the 10 mcg strength (white plunger) and the 20 mcg strength (blue plunger). Each syringe is designed to be used , but you can select the dose that will be delivered:
  • If you deliver a partial dose u2013 this is normal.
  • MAKE SURE YOU HAVE THE CORRECT STRENGTH OF CAVERJECT IMPULSE to deliver your assigned dose
  • INSTRUCTIONS for PREPARING the SYRINGE (Step 1 through Step 12)
  • How to give the injection
  • Do not
  • After your injection:
  • Dispose of your used CAVERJECT IMPULSE syringes and needle.
  • How should I store CAVERJECT IMPULSE?
  • Keep CAVERJECT IMPULSE and all medicines out of the reach of children.
  • This Patient Information and Instructions 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.
  • Rx only
  • Manufactured by:
  • LAB-0641-6.0October 2016
  • Caverject Impulsen
  • Dual Chamber Systemalprostadil for injection
  • 10 micrograms
  • KEEP OUT OF REACH OF CHILDREN
  • Pharmacia & Upjohn CoDIVISION OF PFIZER INC, NY, NY 10017MADE IN BELGIUM
  • 8Q3129
  • LOT/EXP
  • Pfizer
  • Caverject Impulsen
  • 10 micrograms
  • NDC 0009-5181-01Contains 2 of NDC 0009-5181-10
  • For intracavernosal use onlyDual Chamber System
  • Contains 2 single dose injection systemsDiluent Contains Benzyl Alcohol
  • Rx only
  • Caverject Impulsen
  • Dual Chamber Systemalprostadil for injection
  • 20 micrograms
  • KEEP OUT OF REACH OF CHILDREN
  • Pharmacia & Upjohn CoDIVISION OF PFIZER INC, NY, NY 10017MADE IN BELGIUM
  • 8Q3130
  • LOT/EXP
  • Pfizer
  • Caverject Impulsen
  • 20 micrograms
  • NDC 0009-5182-01Contains 2 of NDC 0009-5182-11
  • For intracavernosal use onlyDual Chamber System
  • Contains 2 single dose injection systemsDiluent Contains Benzyl Alcohol
  • Rx only

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