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Ketoconazole (Ketoconazole)

Trade Name : Ketoconazole

PD-Rx Pharmaceuticals, Inc.

TABLET

Strength 200 mg/1

KETOCONAZOLE Azole Antifungal [EPC],Azoles [CS],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]

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Product information is meant for

Wholesalers Suppliers Exporters Doctors MOH Tender Supplies Hospitals Brand CROs Comparator Supplies Generic Cooperate Sourcing Individual Patients Indian Institutional Buyers

Disclaimer

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 Ketoconazole (Ketoconazole) which is also known as Ketoconazole and Manufactured by PD-Rx Pharmaceuticals, Inc.. It is available in strength of 200 mg/1 per ml. Read more

Ketoconazole (Ketoconazole) 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

Packaging and Delivery

Validated Cold Chain Shipment

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
  • Because ketoconazole tablets have been associated with serious adverse reactions (see n n n section), ketoconazole tablets are not indicated for treatment of onychomycosis, cutaneous dermatophyte infections, or Candida infections.n nn
  • Ketoconazole tablets should be used only when other effective antifungal therapy is not available or tolerated and the potential benefits are considered to outweigh the potential risks.
  • Hepatotoxicity:
  • QT Prolongation and Drug Interactions Leading to QT Prolongation:
  • Ketoconazole tablets, USP are a synthetic broad-spectrum antifungal agent available in scored white tablets, each containing 200 mg ketoconazole base for oral administration. Inactive ingredients are colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Ketoconazole is (u00b1)-n n n -1-Acetyl-4-[p-[[2-(2,4-dichlorophenyl)-2-(imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxyl]phenyl] piperazine and has the following structural formula:n nn
  • Ketoconazole, USP is a white or almost white powder, odorless powder, soluble in acids, with a molecular weight of 531.43.
  • No data
  • No data
  • Ketoconazole tablets are not indicated for treatment of onychomycosis, cutaneous dermatophyte infections, or Candida infections.
  • Ketoconazole tablets should be used only when other effective antifungal therapy is not available or tolerated and the potential benefits are considered to outweigh the potential risks.
  • Ketoconazole tablets are indicated for the treatment of the following systemic fungal infections in patients who have failed or who are intolerant to other therapies: blastomycosis, coccidioidomycosis, histoplasmosis, chromomycosis, and paracoccidioidomycosis. Ketoconazole tablets should not be used for fungal meningitis because it penetrates poorly into the cerebrospinal fluid.
  • No data
  • Because of the serious adverse reactions that have been reported in association with ketoconazole, including fatal hepatotoxicity, ketoconazole tablets are not indicated for treatment of onychomycosis, cutaneous dermatophyte infections, or Candida infections.
  • Ketoconazole tablets should be used only when other effective antifungal therapy is not available or tolerated and the potential benefits are considered to outweigh the potential risks.
  • No data
  • Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
  • The following adverse reactions were reported in clinical trials:
  • Arrayn- Immune System Disorders:
  • Arrayn- Endocrine Disorders:
  • Arrayn- Metabolism and Nutrition Disorders:
  • Arrayn- Psychiatric Disorders:
  • Arrayn- Nervous System Disorders
  • Arrayn- Eye Disorders:
  • Arrayn- Vascular Disorders:
  • Arrayn- Respiratory, Thoracic and Mediastinal Disorders:
  • Arrayn- Gastrointestinal Disorders:
  • Arrayn- Hepatobiliary Disorders:
  • Arrayn- Skin and Subcutaneous Tissues Disorders:
  • Arrayn- Musculoskeletal and Connective Tissue Disorders:
  • Arrayn- Reproductive System and Breast Disorders:
  • Arrayn- General Disorders and Administration Site Conditions
  • Arrayn- Investigations:
  • Post-Marketing Experience:u00a0
  • The following adverse reactions were reported during post-marketing experience:
  • Arrayn- Blood and Lymphatic System Disorders:
  • Arrayn- Immune System Disorders:
  • Arrayn- Endocrine Disorders:
  • Arrayn- Nervous System Disorders:
  • Arrayn- Hepatobiliary Disorders:
  • Arrayn- Skin and Subcutaneous Tissue Disorders:
  • Arrayn- Musculoskeletal and Connective Tissue Disorders:
  • Arrayn- Reproductive System and Breast Disorders:
  • In the event of acute accidental overdose, treatment consists of supportive and symptomatic measures. Within the first hour after ingestion, activated charcoal may be administered.
  • There should be laboratory as well as clinical documentation of infection prior to starting ketoconazole therapy. The usual duration of therapy for systemic infection is 6 months. Treatment should be continued until active fungal infection has subsided.
  • Ketoconazole Tablets, USP are available containing 200 mg of ketoconazole, USP.
  • The 200 mg tablets are white to off-white round, scored tablets debossed with n n n above the score and n n n below the score on one side of the tablet and blank on the other side. They are available as follows:n nn
  • u00a0u00a0u00a0u00a0NDC 43063-036-30n n n u00a0u00a0u00a0u00a0bottles of 30 tabletsn nn
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F). [See USP Controlled Room Temperature.]
  • Protect from moisture.
  • Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
  • Keep out of reach of children.
  • PHARMACIST:
  • This Medication Guide has been approved by the U.S. Food and Drug Administration.
  • Mylan Pharmaceuticals Inc.
  • Revised: 3/2018n n n KTCZ:R6m/MG:KTCZ:R3mn nn
  • Ketoconazolen- Tablets, USPn- 200 mg
  • PHARMACIST: Dispense the accompanyingn- Medication Guide to each patient.
  • Rx only
  • Each tablet contains:n n nKetoconazole, USP 200 mgn
  • Dispense in a tight, light-resistantn n ncontainer as defined in the USPn n nusing a child-resistant closure.n
  • Keep container tightly closed.
  • Keep this and all medicationn- out of the reach of children.
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F).n- [See USP Controlled Roomn- Temperature.]
  • Protect from moisture.
  • Usual Dosage:

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With shifting of pharma industry from synthetic molecules to biologic

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