Ranitidine (Ranitidine)

Trade Name : Ranitidine

NCS HealthCare of KY, Inc dba Vangard Labs

TABLET, FILM COATED

Strength 150 mg/1

RANITIDINE HYDROCHLORIDE 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 NCS HealthCare of KY, Inc dba Vangard Labs. It is available in strength of 150 mg/1 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

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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.

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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  • u00a0u00a0u00a0u00a0The active ingredient in ranitidine tablets USP 150 mg and 300 mg is ranitidine hydrochloride (HCl), USP, a histamine H-receptor antagonist. Chemically it is N[2-[[[5-[(dimethylamino)methyl]-2-furanyl]methyl]thio]ethyl]-N'-methyl-2-nitro-1,1-ethenediamine, HCl. It has the following structure:
  • u00a0u00a0u00a0u00a0The empirical formula is CHNOSu2022HCl, representing a molecular weight of 350.87.
  • u00a0u00a0u00a0u00a0Ranitidine HCl USP is a white to pale yellow, granular substance that is soluble in water. It has a slightly bitter taste and sulfur like odor.
  • u00a0u00a0u00a0u00a0Each ranitidine tablet USP 150 mg for oral administration contains 168 mg of ranitidine HCl USP equivalent to 150 mg of ranitidine. Each tablet also contains the inactive ingredients microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, FD&C Red # 40 Aluminum Lake, hypromellose, titanium dioxide, triacetin.
  • u00a0u00a0u00a0u00a0Each ranitidine tablet USP 300 mg for oral administration contains 336 mg of ranitidine HCl USP equivalent to 300 mg of ranitidine. Each tablet also contains the inactive ingredients microcrystalline cellulose, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, FD&C Red # 40 Aluminum Lake, hypromellose, titanium dioxide, triacetin.
  • u00a0u00a0u00a0u00a0Ranitidine is a competitive, reversible inhibitor of the action of histamine at the histamine H-receptors, including receptors on the gastric cells. Ranitidine does not lower serum Ca++ in hypercalcemic states. Ranitidine is not an anticholinergic agent.
  • Clinical Trials: Active Duodenal Ulcer:
  • In these studies, patients treated with ranitidine reported a reduction in both daytime and nocturnal pain, and they also consumed less antacid than the placebo-treated patients.
  • u00a0u00a0u00a0u00a0Foreign studies have shown that patients heal equally well with 150 mg twice daily and 300 mg at bedtime (85% versus 84%, respectively) during a usual 4-week course of therapy. If patients require extended therapy of 8 weeks, the healing rate may be higher for 150 mg twice daily as compared to 300 mg at bedtime (92% versus 87%, respectively).
  • u00a0u00a0u00a0u00a0Studies have been limited to short-term treatment of acute duodenal ulcer. Patients whose ulcers healed during therapy had recurrences of ulcers at the usual rates.
  • u00a0u00a0u00a0u00a0Ranitidine tablets USP are indicated in:
  • 1. Short-term treatment of active duodenal ulcer. Most patients heal within 4 weeks. Studies available to date haveu00a0not assessed the safety of ranitidine in uncomplicated duodenal ulcer for periods of more than 8 weeks.
  • 2. Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers. No placebo-controlled comparative studies have been carried out for periods of longer than 1 year.
  • 3. The treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome and systemic mastocytosis).
  • 4. Short-term treatment of active, benign gastric ulcer. Most patients heal within 6 weeks and the usefulness of further treatment has not been demonstrated. Studies available to date have not assessed the safety of ranitidine in uncomplicated, benign gastric ulcer for periods of more than 6 weeks.
  • 5. Maintenance therapy for gastric ulcer patients at reduced dosage after healing of acute ulcers. Placebo-controlled studies have been carried out for 1 year.
  • 6. Treatment of GERD. Symptomatic relief commonly occurs within 24 hours after starting therapy with ranitidine 150 mg twice daily.
  • 7. Treatment of endoscopically diagnosed erosive esophagitis. Symptomatic relief of heartburn commonly occurs within 24 hours of therapy initiation with ranitidine 150 mg 4 times daily.
  • 8. Maintenance of healing of erosive esophagitis. Placebo-controlled trials have been carried out for 48 weeks.
  • u00a0u00a0u00a0u00a0Concomitant 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.
  • u00a0u00a0u00a0u00a0Ranitidine tablets USP are contraindicated for patients known to have hypersensitivity to the drug or any of the ingredients (see ).
  • No data
  • u00a0u00a0u00a0u00a0The following have been reported as events in clinical trials or in the routine management of patients treated with ranitidine. The relationship to therapy with ranitidine has been unclear in many cases. Headache, sometimes severe, seems to be related to administration of ranitidine.
  • u00a0u00a0u00a0u00a0There 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 ). In addition, abnormalities of gait and hypotension have been reported.
  • u00a0u00a0u00a0u00a0When overdosage occurs, the usual measures to remove unabsorbed material from the gastrointestinal tract, clinical monitoring, and supportive therapy should be employed.
  • u00a0u00a0u00a0u00a0Studies in dogs receiving dosages of ranitidine 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.
  • No data
  • u00a0u00a0u00a0u00a0Ranitidine tablets USP 150 mg (ranitidine HCl USP equivalent to 150 mg of ranitidine) are pink colored, circular, biconvex, beveled edge film coated tablets with engraved on one side, on the other side. They are available in blistercards of 30 (NDC 0615-8021-39), blistercards of 15 (NDC 0615-8021-05)u00a0andu00a0unit dose boxes of 30u00a0(NDC 0615-8021-30) tablets.
  • u00a0u00a0u00a0u00a0Ranitidine tablets USP 300 mg (ranitidine HCl USP equivalent to 300 mg of ranitidine) are pink colored, circular, biconvex, beveled edge film coated tablets with engraved on one side on the other side.
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F); excursions permitted to 15 to 30 C (59 to 86 F) [see USP Controlled Room Temperature]. Protect from light. Replace cap securely after each opening.
  • Manufactured by:
  • Strides Shasun Limited,
  • Unit-II, R.S. No. 32, 33 & 34,u00a0PIMS RoadPeriyakalapet, Puducherry - 605 014, India.
  • PON/DRUGS/16 13 4193
  • Manufactured for:
  • Glenmark Pharmaceuticals Inc., USA
  • Questions? 1 (888)721-7115n n
  • February 2016
  • 020003329
  • MULTISTIX is a registered trademark of Bayer Healthcare LLC.
  • No data

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