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Ranitidine (Ranitidine)

Trade Name : Ranitidine

Sandoz Inc.

SYRUP

Strength 15 mg/mL

RANITIDINE Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC]

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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 Ranitidine (Ranitidine) which is also known as Ranitidine and Manufactured by Sandoz Inc.. It is available in strength of 15 mg/mL per ml. Read more

Ranitidine (Ranitidine) 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
  • The active ingredient in ranitidine syrup (ranitidine oral solution, USP) is ranitidine hydrochloride (HCl), USP, a histamine H-receptor antagonist. Chemically it is N[2-[[[5-[(dimethylamino)methyl]-2-furanyl]methyl]thio]ethyl]-Nu2019-methyl-2-nitro-1,1-ethenediamine, HCl. It has the following structure:
  • The empirical formula is CHNOSu2022HCl, representing a molecular weight of 350.87.
  • Ranitidine HCl is a white to pale yellow, granular substance that is soluble in water. It has a slightly bitter taste and sulfurlike odor.
  • Each mL of ranitidine oral solution, USP contains 16.8 mg of ranitidine HCl equivalent to 15 mg of ranitidine. Ranitidine oral solution, USP also contains the inactive ingredients alcohol, butylparaben, dibasic sodium phosphate heptahydrate, hypromellose, peppermint flavor, monobasic potassium phosphate, propylparaben, purified water, saccharin sodium, sodium chloride, and sorbitol.
  • Ranitidine oral solution, USP is a competitive, reversible inhibitor of the action of histamine at the histamine H-receptors, including receptors on the gastric cells. Ranitidine oral solution, USP does not lower serum Ca++ in hypercalcemic states. Ranitidine oral solution, USP is not an anticholinergic agent.
  • Ranitidine oral solution, USP is indicated in:
  • Concomitant antacids should be given as needed for pain relief to patients with active duodenal ulcer; active, benign gastric ulcer; hypersecretory states; GERD; and erosive esophagitis.
  • Ranitidine oral solution, USP is contraindicated for patients known to have hypersensitivity to the drug or any of the ingredients (see PRECAUTIONS).
  • General:
  • The following have been reported as events in clinical trials or in the routine management of patients treated with ranitidine oral solution, USP. The relationship to therapy with ranitidine oral solution, USP has been unclear in many cases. Headache, sometimes severe, seems to be related to administration of ranitidine oral solution, USP.
  • Central Nervous System:
  • Cardiovascular:
  • Gastrointestinal:
  • Hepatic:
  • Musculoskeletal:
  • Hematologic:
  • Endocrine:
  • Integumentary:
  • Respiratory:
  • Other:
  • There has been limited experience with overdosage. Reported acute ingestions of up to 18 g orally have been associated with transient adverse effects similar to those encountered in normal clinical experience (see ADVERSE REACTIONS). In addition, abnormalities of gait and hypotension have been reported.
  • When overdosage occurs, the usual measures to remove unabsorbed material from the gastrointestinal tract, clinical monitoring, and supportive therapy should be employed.
  • Studies in dogs receiving dosages of ranitidine oral solution, USP in excess of 225 mg/kg/day have shown muscular tremors, vomiting, and rapid respiration. Single oral doses of 1,000 mg/kg in mice and rats were not lethal. Intravenous LD values in mice and rats were 77 and 83 mg/kg, respectively.
  • Active Duodenal Ulcer: n- Active Duodenal Ulcer
  • Antacid should be given as needed for relief of pain (see CLINICAL PHARMACOLOGY: Pharmacokinetics).
  • Maintenance of Healing of Duodenal Ulcers:
  • Pathological Hypersecretory Conditions (such as Zollinger-Ellison syndrome):
  • The current recommended adult oral dosage is 150 mg or 10 mL of oral solution (2 teaspoonfuls of oral solution equivalent to 150 mg of ranitidine) twice daily. In some patients it may be necessary to administer ranitidine oral solution, USP 150-mg doses more frequently. Dosages should be adjusted to individual patient needs, and should continue as long as clinically indicated. Dosages up to 6 g/day have been employed in patients with severe disease.
  • Benign Gastric Ulcer:
  • Maintenance of Healing of Gastric Ulcers:
  • GERD:
  • Erosive Esophagitis:
  • Maintenance of Healing of Erosive Esophagitis:
  • Pediatric Use:
  • The following 3 subsections provide dosing information for each of the pediatric indications.
  • Treatment of Duodenal and Gastric Ulcers:
  • Maintenance of Healing of Duodenal and Gastric Ulcers:
  • Treatment of GERD and Erosive Esophagitis:
  • Dosage Adjustment for Patients With Impaired Renal Function:
  • Elderly patients are more likely to have decreased renal function, therefore caution should be exercised in dose selection, and it may be useful to monitor renal function (see CLINICAL PHARMACOLOGY: Pharmacokinetics: Geriatrics and PRECAUTIONS: Geriatric Use).
  • Ranitidine Oral Solution, USP, is a clear, pale yellow, peppermint-flavored liquid. Each mL contains 16.8 mg of ranitidine hydrochloride equivalent to 15 mg of ranitidine supplied in bottles of 16 fluid ounces (one pint) (NDC 0781-6087-16).
  • Store between 4u00b0 and 25u00b0C (39u00b0 and 77u00b0F) [see USP Controlled Room Temperature]. Do not freeze. Dispense in tight, light-resistant containers as defined in the USP/NF.
  • Call your doctor for medical advice about side effects.u00a0 You may report side effects to FDA at 1-800-FDA-1088.
  • Manufactured byTOLMAR Inc.Fort Collins, CO 80526 forSandoz Inc.Princeton, NJ 08540
  • 44431 Rev. 0 10/10
  • MULTISTIX is a registered trademark of Bayer Healthcare LLC.
  • No data

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Comparator Sourcing for Clinical Trials

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Validated Cold Chain Shipment

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