“We use cookies on this website to enhance your user experience and to personalise content. By clicking any link or continuing to use our Website you agree to our cookies as per our Privacy Policy. Read More” Ok, I agree

Lansoprazole (Lansoprazole)

Trade Name : Lansoprazole

Teva Pharmaceuticals USA, Inc.

CAPSULE, DELAYED RELEASE

Strength 15 mg/1

LANSOPRAZOLE Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Inhibition Gastric Acid Secretion [PE]

Delivery Process

Submit a Request

You can fill in a request for your medicine through the form provided. You can access the form by clicking on the ‘Get Price’ button.

We’ll Get in Touch

Once we review your request, we’ll send you an estimated price for the medicine within 2-5 days.

Confirmation and Payment

You can fill in a request for your medicine through the form provided. You can access the form by clicking on the ‘Get Price’ button.

Submit a Request

You can fill in a request for your medicine through the form provided. You can access the form by clicking on the ‘Get Price’ button.

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 Lansoprazole (Lansoprazole) which is also known as Lansoprazole and Manufactured by Teva Pharmaceuticals USA, Inc.. It is available in strength of 15 mg/1 per ml. Read more

Lansoprazole (Lansoprazole) 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.

Inquire directly from our website and get 5% off on any medicine!

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.

Read more

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.

Read more
  • No data
  • No data
  • Lansoprazole delayed-release capsules are a proton pump inhibitor (PPI) indicated for the:
  • u2022 Treatment of active duodenal ulcer in adults. ()
  • u2022 Eradication of to reduce the risk of duodenal ulcer recurrence in adults. ()
  • u2022 Maintenance of healed duodenal ulcers in adults. ()
  • u2022 Treatment of active benign gastric ulcer in adults. ()
  • u2022 Healing of non-steroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults. ()
  • u2022 Risk reduction of NSAID-associated gastric ulcer in adults. ()
  • u2022 Treatment of symptomatic gastroesophageal reflux disease (GERD) in adults and pediatric patients 1 year of age and older. ()
  • u2022 Treatment of erosive esophagitis (EE) in adults and pediatric patients 1 year of age and older. ()
  • u2022 Maintenance of healing of EE in adults. ()
  • Pathological hypersecretory conditions, including Zollinger-Ellison syndrome (ZES) in adults. ()
  • Recommended Dosage
  • 2.4
  • Lansoprazole delayed-release capsules
  • See full prescribing information for alternative administration options.
  • Capsules: 15 mg and 30 mg. ()
  • No data
  • Contraindicated in patients with known severe hypersensitivity to any component of the lansoprazole delayed-release capsule formulation. ()
  • Patients receiving rilpivirine-containing products. (, )
  • No data
  • Gastric Malignancy:
  • Acute Interstitial Nephritis:
  • Arrayn- Clostridium difficile
  • Bone Fracture:
  • Cutaneous and Systemic Lupus Erythematosus:
  • Cyanocobalamin (Vitamin B12) Deficiency:
  • Hypomagnesemia:
  • Interactions with Investigations for Neuroendocrine Tumors
  • Interaction with Methotrexate
  • Fundic Gland Polyps
  • The following serious adverse reactions are described below and elsewhere in labeling:
  • Most commonly reported adverse reactions (u2265 1%): diarrhea, abdominal pain, nausea and constipation. ()
  • To report SUSPECTED ADVERSE REACTIONS, contact TEVA PHARMACEUTICALS USA, INC. at 1-888-838-2872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • Tables 2 and 3 include drugs with clinically important drug interactions and interaction with diagnostics when administered concomitantly with lansoprazole and instructions for preventing or managing them.
  • Consult the labeling of concomitantly used drugs to obtain further information about interactions with PPIs.
  • See full prescribing information for a list of clinically important drug interactions. ()
  • No data
  • Pregnancy
  • Pediatrics
  • Lansoprazole is not removed from the circulation by hemodialysis. In one reported overdose, a patient consumed 600 mg of lansoprazole with no adverse reaction. Oral lansoprazole doses up to 5000 mg/kg in rats [approximately 1300 times the 30 mg human dose based on body surface area (BSA)] and in mice (about 675.7 times the 30 mg human dose based on BSA) did not produce deaths or any clinical signs.
  • In the event of over-exposure, treatment should be symptomatic and supportive.
  • If over-exposure occurs, call your poison control center at 1-800-222-1222 for current information on the management of poisoning or over-exposure.
  • The active ingredient in lansoprazole delayed-release capsules USP is lansoprazole, USP, a substituted benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl]methyl]sulfinyl] benzimidazole, a compound that inhibits gastric acid secretion. Lansoprazole, USP has the following structure:
  • CHFNOS M.W. 369.36
  • Lansoprazole, USP is a white to brownish-white odorless crystalline powder which melts with decomposition at approximately 166u00b0C. Lansoprazole, USP is freely soluble in dimethylformamide; soluble in methanol; sparingly soluble in ethanol; slightly soluble in ethyl acetate, dichloromethane and acetonitrile; very slightly soluble in ether; and practically insoluble in hexane and water.
  • Lansoprazole, USP is stable when exposed to light for up to two months. The rate of degradation of the compound in aqueous solution increases with decreasing pH. The degradation half-life of the drug substance in aqueous solution at 25u00b0C is approximately 0.5 hour at pH 5 and approximately 18 hours at pH 7.
  • The lansoprazole delayed-release capsules USP for oral administration are available in two dosage strengths: 15 mg and 30 mg of lansoprazole, USP per capsule. Each delayed-release capsule contains enteric-coated granules consisting of 15 mg or 30 mg of lansoprazole, USP (active ingredient) and the following inactive ingredients: black iron oxide, gelatin, hypromellose, magnesium carbonate, methacrylic acid copolymer dispersion, propylene glycol, red iron oxide, shellac, sugar spheres (which contain sucrose and corn starch), talc, titanium dioxide, and triethyl citrate. Additionally, 15 mg capsule contains brilliant blue FCF - FD&C blue 1.
  • No data
  • In two 24 month carcinogenicity studies, Sprague-Dawley rats were treated with oral lansoprazole doses of 5 to 150 mg/kg/day, about one to 40 times the exposure on a body surface (mg/m) basis of a 50 kg person of average height [1.46 m body surface area (BSA)] given the recommended human dose of 30 mg/day. Lansoprazole produced dose-related gastric enterochromaffin-like (ECL) cell hyperplasia and ECL cell carcinoids in both male and female rats. It also increased the incidence of intestinal metaplasia of the gastric epithelium in both sexes. In male rats, lansoprazole produced a dose-related increase of testicular interstitial cell adenomas. The incidence of these adenomas in rats receiving doses of 15 to 150 mg/kg/day (four to 40 times the recommended human dose based on BSA) exceeded the low background incidence (range = 1.4 to 10%) for this strain of rat.
  • In a 24 month carcinogenicity study, CD-1 mice were treated with oral lansoprazole doses of 15 to 600 mg/kg/day, two to 80 times the recommended human dose based on BSA. Lansoprazole produced a dose-related increased incidence of gastric ECL cell hyperplasia. It also produced an increased incidence of liver tumors (hepatocellular adenoma plus carcinoma). The tumor incidences in male mice treated with 300 and 600 mg/kg/day (40 to 80 times the recommended human dose based on BSA) and female mice treated with 150 to 600 mg/kg/day (20 to 80 times the recommended human dose based on BSA) exceeded the ranges of background incidences in historical controls for this strain of mice. Lansoprazole treatment produced adenoma of rete testis in male mice receiving 75 to 600 mg/kg/day (10 to 80 times the recommended human dose based on BSA).
  • A 26 week p53 (+/-) transgenic mouse carcinogenicity study was not positive.
  • Lansoprazole was positive in the Ames test and the human lymphocyte chromosomal aberration assay. Lansoprazole was not genotoxic in the rat hepatocyte unscheduled DNA synthesis (UDS) test, the mouse micronucleus test, or the rat bone marrow cell chromosomal aberration test.
  • Lansoprazole at oral doses up to 150 mg/kg/day (40 times the recommended human dose based on BSA) was found to have no effect on fertility and reproductive performance of male and female rats.
  • No data
  • Lansoprazole Delayed-Release Capsules USP are available as follows:
  • 15 mg - hard gelatin capsules, with a light-blue opaque cap and flesh-colored opaque body, imprinted with u201c93u201d and u201c7350u201d, filled with off-white to beige pellets, in bottles of 30 (NDC 0093-7350-56).
  • 30 mg - hard gelatin capsules, with a light-gray opaque cap and flesh-colored opaque body, imprinted with u201c93u201d and u201c7351u201d, filled with off-white to beige pellets, in bottles of 30 (NDC 0093-7351-56).
  • 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, with a child-resistant closure (as required).
  • KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
  • Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use).
  • Advise patients to:
  • Acute Interstitial Nephritis
  • To call their healthcare provider if they experience signs and/or symptoms associated with acute interstitial nephritis .
  • Arrayn- Clostridium difficile
  • To immediately call their healthcare provider if they experience diarrhea that does not improve .
  • Bone Fracture
  • To report any fractures, especially of the hip, wrist or spine, to their healthcare provider .
  • Cutaneous and Systemic Lupus Erythematosus
  • To immediately call their healthcare provider for any new or worsening of symptoms associated with cutaneous or systemic lupus erythematosus.
  • Cyanocobalamin (Vitamin B12) Deficiency
  • To report any clinical symptoms that may be associated with cyanocobalamin deficiency to their healthcare provider, if they have been receiving lansoprazole for longer than three years .
  • Hypomagnesemia
  • To report any clinical symptoms that may be associated with hypomagnesemia to their healthcare provider, if they have been receiving lansoprazole for at least three months .
  • Drug Interactions
  • Advise patients to report to their healthcare provider if they are taking rilpivirine-containing products or high-dose methotrexate .
  • Pregnancy
  • Advise a pregnant woman of the potential risk to a fetus. Advise females of reproductive potential to inform their healthcare provider of a known or suspected pregnancy .
  • Administration
  • Lansoprazole Delayed-Release Capsules
  • Manufactured In Israel By:n Jerusalem, 9777402, Israel
  • Manufactured For:n North Wales, PA 19454
  • Rev. O 6/2018
  • Lansoprazole (lan-SOH-pru0259-zohl) Delayed-Release Capsules, for oral use
  • What is the most important information that I should know about lansoprazole delayed-release capsules?
  • You should take lansoprazole delayed-release capsules exactly as prescribed, at the lowest dose possible and for the shortest time needed.
  • Lansoprazole delayed-release capsules may help your acid-related symptoms, but you could still have serious stomach problems. Talk with your doctor.
  • Lansoprazole delayed-release capsules can cause serious side effects, including:
  • Talk to your doctor about your risk of these serious side effects.
  • Lansoprazole delayed-release capsules can have other serious side effects. See n
  • What are lansoprazole delayed-release capsules?
  • A prescription medicine called a proton pump inhibitor (PPI) used to reduce the amount of acid in your stomach.
  • In adults, lansoprazole delayed-release capsules are used for:
  • Pediatrics:
  • Give lansoprazole delayed-release capsules exactly as prescribed by your childu2019s doctor. Do not increase the dose of lansoprazole delayed-release capsules or give your child lansoprazole delayed-release capsules longer than the amount of time your doctor tells you to.
  • In children 1 to 11 years of age
  • In children 12 to 17 years of age
  • Lansoprazole delayed-release capsules are not effective for treating the symptoms of GERD in children less than 1 year of age.
  • Do not take lansoprazole delayed-release capsules if you are:
  • Before you take lansoprazole delayed-release capsules, tell your doctor about all of your medical conditions, including if you:
  • Tell your doctor about all the medicines you take,n- Especially tell your doctor
  • How should I take lansoprazole delayed-release capsules?
  • Lansoprazole delayed-release capsules:
  • If you take too many lansoprazole delayed-release capsules, call your doctor or your poison control center at 1-800-222-1222 right away or go to the nearest hospital emergency room.
  • What are the possible side effects of lansoprazole delayed-release capsules?
  • Lansoprazole delayed-release capsules can cause serious side effects, including:
  • T diarrhea, stomach-area (abdomen) pain, nausea and constipation.
  • These are not all the possible side effects of lansoprazole delayed-release capsules.
  • Call your doctor for medical advice about side effects.
  • You may report side effects to FDA at 1-800-FDA-1088.
  • How should I store lansoprazole delayed-release capsules?
  • Store lansoprazole delayed-release capsules at room temperature between 68u00b0F to 77u00b0F (20u00b0C to 25u00b0C).
  • Keep lansoprazole delayed-release capsules and all medicines out of the reach of children.
  • General information about the safe and effective use of lansoprazole delayed-release capsules
  • Medicines are sometimes prescribed for conditions other than those listed in a Medication Guide. Do not use lansoprazole delayed-release capsules for conditions for which they were not prescribed. Do not give lansoprazole delayed-release capsules to other people, even if they have the same symptoms that you have. They may harm them. You can ask your doctor or pharmacist for information about lansoprazole delayed-release capsules that is written for health professionals.
  • What are the ingredients in lansoprazole delayed-release capsules?
  • Active ingredient:
  • Inactive ingredients in lansoprazole delayed-release capsules:
  • For more information, call 1-888-838-2872.
  • All brand names listed are the registered trademarks of their respective owners and are not trademarks of Teva Pharmaceuticals USA, Inc.
  • Manufactured In Israel By:n Jerusalem, 9777402, Israel
  • Manufactured For:n North Wales, PA 19454
  • This Medication Guide has been approved by the U.S. Food and Drug Administration.
  • Rev. E 6/2018
  • Lansoprazole (lan-SOH-pru0259-zohl) Delayed-Release Capsules, for oral use
  • Important:
  • Lansoprazole delayed-release capsules
  • Taking lansoprazole delayed-release capsules with certain foods:
  • You can only use applesauce, ENSURE pudding, cottage cheese, yogurt or strained pears.
  • Taking lansoprazole delayed-release capsules with certain juices:
  • You can only use apple juice, orange juice or tomato juice.
  • Giving lansoprazole delayed-release capsules through a nasogastric tube (NG tube) size 16 French or larger:
  • You can only use apple juice.
  • How should I store lansoprazole delayed-release capsules?
  • Keep lansoprazole delayed-release capsules and all medicines out of the reach of children.
  • This Instruction for Use has been approved by the U.S. Food and Drug Administration.
  • Manufactured In Israel By:n Jerusalem, 9777402, Israel
  • Manufactured For:n North Wales, PA 19454
  • Rev. D 6/2018
  • NDC n- 7350
  • Lansoprazole
  • Delayed-Release
  • Capsules USP, 15 mg
  • PHARMACIST: PLEASE DISPENSE
  • WITH ATTACHED MEDICATION GUIDE
  • Rx only
  • 30 CAPSULES
  • TEVAn n n n
  • NDC n- 7351
  • Lansoprazole
  • Delayed-Release
  • Capsules USP, 30 mg
  • PHARMACIST: PLEASE DISPENSE
  • WITH ATTACHED MEDICATION GUIDE
  • Rx only
  • 30 CAPSULES
  • TEVAn n n n

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Desogestrel And Ethinyl Estradiol (Emoquette)

Manufacturer: REMEDYREPACK INC.

Presentation: KIT

Strength:

Pack Size:

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Manufacturer: REMEDYREPACK INC.

Presentation: TABLET

Strength: 2.5; .025 mg/1; mg/1

Pack Size:

Fluoxetine Hydrochloride (Fluoxetine)

Fluoxetine Hydrochloride (Fluoxetine)

Manufacturer: REMEDYREPACK INC.

Presentation: CAPSULE

Strength: 40 mg/1

Pack Size:

Metoprolol Succinate (Metoprolol Succinate)

Metoprolol Succinate (Metoprolol Succinate)

Manufacturer: REMEDYREPACK INC.

Presentation: TABLET, EXTENDED RELEASE

Strength: 25 mg/1

Pack Size:

Losartan Potassium (Losartan Potassium)

Losartan Potassium (Losartan Potassium)

Manufacturer: REMEDYREPACK INC.

Presentation: TABLET, FILM COATED

Strength: 25 mg/1

Pack Size:

Browse Our Services And Processes

Comparator Sourcing for Clinical Trials

Comparator Sourcing for Clinical Trials

GNH India brings over 10 years of experience in Comparator

Read More

Name Patient Supply

Name Patient Supply

Today, the exact cause for many rare diseases remains unknown

Read More

Validated Cold Chain Shipment

Validated Cold Chain Shipment

With shifting of pharma industry from synthetic molecules to biologic

Read More

Clinical Trials Supply

Clinical Trials Supply

STOP SOURCING..... START SMART SOURCING...... COME STRAIGHT TO THE SOURCE

Read More

Pharmaceutical Contract Manufacturing

Pharmaceutical Contract Manufacturing

GNH Provides Contract Manufacturing services for: Generic Medicines with following

Read More

Pricing

Pricing

PRICING POLICY Terms of sales are typically prepaid, unless otherwise

Read More

Disclaimer

Please see the Legal Notice for detailed terms and disclaimers. The Legal Notice governs the use of this Website and by accessing and using this Website you agree to be bound by and accept the Legal Notice.

Browse from other international pharmaceuticals

General

64020 Products

GNH India Brings to over 64036 Product SKUs from India all at 1 place with easy access and global deliveries.

US NDC

71245 Products

GNH India Brings to over 71252 Product SKUs from India all at 1 place with easy access and global deliveries.

Canadian DIN

51046 Products

GNH India Brings to over 51047 Product SKUs from India all at 1 place with easy access and global deliveries.

Swiss Drugs

150 Products

GNH India Brings to over 150 Product SKUs from India all at 1 place with easy access and global deliveries.

NZ Drugs

13296 Products

GNH Brings to over 13298 Product SKUs from India all at 1 place with easy access and global deliveries.

FAQ

Check out our delivery process

Can’t find what
you’re looking for?

Contact US
Get Price

Are you an existing customer or a vendor of GNH India? Log in here to

View your Transaction
COMPANY
SERVICES
QUICK LINKS
CONTACT US
Registered Office Address:

Unit # G- 14, 15, 16, 17, Ground Floor, Prabhadevi Industrial Estate, Enterprises Industrial Premises, 408, Veer Sawarkar Road, Prabhadevi,
Mumbai 400025 India

US Office Address:

GNH Pharmaceuticals USA LLC,
Suite E # 499, 1235 EAST BLVD,
Charlotte, NC, 28203, U.S.A
TEL: +1 704 557 0412

Pharmexcil
DB
FIEO-2016
SiteLock

Copyright © 2024 GNHIndia .com. All Rights Reserved. Please read Legal Notice for further details.

Disclaimer: Product names, logos, brands and other trademarks featured or referred to are the property of their respective trademark holders.