Ranitidine Tablets USP 150mg Technical Specification:
Product Name: | Ranitidine Tablets USP |
Brand Name: | Generic |
Strength: | 150mg, 300mg |
Dosage Form: | Tablets(Film coated) |
Route of Administration: | Via Oral Route |
Packing: | 10s, 30s, 100s, 500s |
Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
Regulatory Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
Therapeutic use: | Gastroenterological, Antacid, Anti-Ulcer |
Indication: | Ranitidine is a medicine that reduces the amount of acid your stomach makes. It was used for indigestion, heartburn and acid reflux, gastro-oesophageal reflux disease (GORD – this is when you keep getting acid reflux), and to prevent and treat stomach ulcers. |
Storage: | Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Ranitidine Tablets USP 150mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Ranitidine Tablets USP 150mg
Each film coated tablet contains:
Ranitidine Hydrochloride USP
Equivalent to Ranitidine 150mg
Excipients q.s.
Colour: Ponceau 4 R
THERAPEUTIC INDICATIONS:
Ranitidine is a medication used to decrease stomach acid production. It is commonly used in treatment of peptic ulcer disease, gastroesophageal reflux disease, and Zollinger–Ellison syndrome.
CAUTION & WARNING:
CAUTION: Read enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.
STORAGE & DOSAGE:
Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Protect from light and moisture.
Dosage: As directed by the Physician
Attach dispensing label as per end county.
Why Taj Pharmaceuticals?
Taj Pharma is your steadfast partner in health, offering excellence in pharmaceuticals, including Ranitidine Tablets. With a commitment to unwavering quality and innovation, we stand out as a reliable choice for healthcare solutions. Our Ranitidine Tablets are crafted to meet the highest industry standards, ensuring effective relief for acid-related conditions.
Healthcare professionals and patients alike trust Taj Pharma for our dedication to patient well-being. Our stringent quality control measures guarantee that every Ranitidine Tablet delivers the relief you need with the safety you deserve. Experience the difference in quality, innovation, and care with Taj Pharma, your trusted source for Ranitidine Tablets and comprehensive healthcare solutions. Your health is our priority.
What is Ranitidine Tablet and its use?
Ranitidine tablets are a medication that belongs to a class of drugs known as H2 (histamine2) receptor antagonists. They are used to treat various conditions related to excessive stomach acid production. Here’s a brief overview of Ranitidine tablets and their common uses:
Active Ingredient: Ranitidine is the active ingredient in these tablets.
Mechanism of Action: Ranitidine works by blocking the action of histamine on the H2 receptors in the stomach. This reduces the production of stomach acid.
Uses:
- Gastroesophageal Reflux Disease (GERD): Ranitidine is often prescribed to manage the symptoms of GERD, a condition in which stomach acid frequently flows back into the esophagus, causing heartburn and irritation.
- Peptic Ulcers: Ranitidine is used to treat and prevent peptic ulcers, which can develop in the stomach or the first part of the small intestine (duodenum). It helps by reducing stomach acid, which can aggravate ulcers.
- Zollinger-Ellison Syndrome: This rare condition is characterized by the overproduction of stomach acid. Ranitidine can be used to control excessive acid secretion in individuals with this syndrome.
- Erosive Esophagitis: When the lining of the esophagus becomes inflamed due to stomach acid exposure, Ranitidine can help reduce inflammation and promote healing.
- Preventive Measures: Ranitidine may also be prescribed to prevent heartburn and acid indigestion that can occur after meals or during the nighttime, especially for those prone to such symptoms.
How does Ranitidine Tablet work?
Ranitidine tablets work by reducing the production of stomach acid. They belong to a class of medications known as H2 (histamine-2) receptor antagonists, and they affect the H2 receptors in the stomach. Here’s how Ranitidine tablets work:
- Role of Histamine: In the stomach, one of the key triggers for the production of gastric acid (hydrochloric acid) is histamine. When food is ingested, histamine is released by certain cells in the stomach lining.
- H2 Receptors: Histamine exerts its effects on stomach acid secretion by binding to specific receptors called H2 receptors that are found on the surface of cells in the stomach’s lining.
- Acid Production: When histamine binds to H2 receptors, it stimulates these cells to produce and release acid into the stomach. This gastric acid is necessary for digestion but can be excessive in certain conditions, leading to issues like heartburn, indigestion, and ulcers.
- Ranitidine’s Action: Ranitidine is an H2 receptor antagonist, which means it blocks the action of histamine on these receptors. By doing so, Ranitidine reduces the stimulation of acid production in the stomach.
- Decreased Acid Production: When Ranitidine is taken, it inhibits the H2 receptors, preventing histamine from signaling the stomach to produce as much acid. As a result, there is a reduction in the volume and acidity of gastric acid produced by the stomach.
Benefits of Ranitidine Tablets:
- Acid Reflux Relief: Ranitidine is often used to relieve symptoms of acid reflux, including heartburn and acid indigestion. It can provide quick relief by reducing stomach acid levels.
- Peptic Ulcer Treatment: Ranitidine is effective in treating and preventing peptic ulcers (ulcers in the stomach or the first part of the small intestine, known as the duodenum). It helps by reducing acid production, allowing ulcers to heal.
- Erosive Esophagitis: For individuals with erosive esophagitis (inflammation and damage to the esophagus due to stomach acid), Ranitidine can help reduce irritation and promote healing.
- Prevention: Ranitidine can be used preventively, especially for individuals who experience heartburn or acid indigestion after meals or during the night.
Potential Side Effects of Ranitidine Tablets:
- Headache: Headaches are a common side effect reported by some individuals taking Ranitidine.
- Nausea and Vomiting: Gastrointestinal side effects like nausea and vomiting may occur in some patients.
- Diarrhea or Constipation: Changes in bowel habits, including diarrhea or constipation, can sometimes be experienced.
- Fatigue or Dizziness: Some individuals may feel fatigued or dizzy while taking Ranitidine.
- Muscle Pain: Muscle pain, also known as myalgia, can occur but is less common.
- Allergic Reactions: In rare cases, allergic reactions may occur, leading to symptoms such as rash, itching, swelling, or difficulty breathing. Seek immediate medical attention if you experience signs of an allergic reaction.
- Potential Long-Term Concerns: There have been concerns about potential impurities, such as NDMA (N-nitrosodimethylamine), in some Ranitidine products. Regulatory agencies in some regions have taken actions, including recalls and restrictions, due to these concerns.
Frequently asked questions about Ranitidine Tablet?
- What is Ranitidine, and how does it work?
Ranitidine is a medication used to reduce stomach acid production. It works by blocking histamine2 receptors in the stomach, which decreases the production of gastric acid.
- What conditions are Ranitidine Tablets commonly used to treat?
Ranitidine is often used to treat conditions such as heartburn, acid indigestion, gastroesophageal reflux disease (GERD), peptic ulcers, and erosive esophagitis.
- How should I take Ranitidine Tablets?
Typically, Ranitidine is taken by mouth with or without food as directed by your healthcare provider. The dosage and frequency will depend on your specific condition and response to treatment.
- Can I take Ranitidine Tablets overthecounter (OTC)?
As of my last knowledge update in September 2021, Ranitidine was available overthecounter in some regions. However, regulatory agencies in certain areas had raised concerns about the presence of impurities in Ranitidine products, leading to recalls and restrictions on its use. Check with your local regulatory authorities and healthcare provider for the latest information.
- Are there any dietary restrictions while taking Ranitidine?
Ranitidine can be taken with or without food. However, it’s advisable to follow your healthcare provider’s advice regarding specific dietary restrictions or recommendations.
- How quickly does Ranitidine provide relief from heartburn and acid indigestion?
Ranitidine can provide relief from heartburn and acid indigestion relatively quickly, often within an hour or less.
- Are there any potential side effects of Ranitidine Tablets?
Common side effects may include headaches, nausea, vomiting, diarrhea, and fatigue. Rarely, there can be allergic reactions or more serious side effects.
- Can I take Ranitidine while pregnant or breastfeeding?
It’s essential to consult with a healthcare provider if you are pregnant, planning to become pregnant, or breastfeeding before using Ranitidine, as they can provide guidance on its safety and suitability.
- Are there any drug interactions with Ranitidine?
Ranitidine may interact with certain medications. Inform your healthcare provider about all medications, supplements, and herbal products you are taking to check for potential interactions.
- Is it safe to use Ranitidine for an extended period?
Extended use of Ranitidine should be discussed with a healthcare provider. They can assess the benefits and risks and recommend appropriate longterm management strategies.
- Why has Ranitidine been in the news regarding recalls and restrictions?
Some regulatory agencies had raised concerns about the presence of low levels of a potentially harmful substance called Nnitrosodimethylamine (NDMA) in Ranitidine products, leading to recalls and restrictions in some regions. The situation may vary by location, so it’s essential to stay informed through local health authorities.
As Ranitidine Tablets Exporters; We can cater to export business queries from the following geographies. We are exporting our Ranitidine Tablets product in the Following Countries-
Russia and CIS Countries: Azerbaijan, Armenia, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, Turkmenistan, Uzbekistan and Ukraine
GCC/ Middle East Countries: Saudi Arabia, Yemen, Oman, Bahrain, UAE, Lebanon, Jordan, and Iraq.
African Countries: Nigeria, Tanzania, Sudan, Zambia, Benin, Angola, Liberia
Southeast Asia: Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand, Vietnam, Brunei Darussalam
Other Asian Countries: Nepal, Myanmar, Malaysia, Cambodia, Bhutan, Sri Lanka, Mauritius
Ranitidine Tablets Regulatory Documents:
- Certificate of Analysis (COA)
- Method of Analysis (MOA)
- Stability Data (Accelerated stability / Long-term stability / Zone 4b)
- CTD Dossier / ACTD Dossiers / eCTD Dossiers
- Certificate of Pharmaceuticals Product (COPP)
- Free Sale Certificate (FSC)
Contact the most reliable manufacturer of Ranitidine Tablets, Taj Pharmaceuticals Limited, to get bulk quantities at a reasonable price.
To Place Orders:
Direct line: +91 8448 444 095 / WhatsApp +91 74 0000 9975 / 74 0000 9976
E-Mail: info@tajpharma.com
Toll free: 1-800-222-434 / Toll free: 1-800-222-825
General EPA BX: +91 22 2637 4592 / +91 22 2637 4593
Fax No: +91 22 2634 1274
GENERIC NAME OF THE MEDICINAL PRODUCT:
A) Ranitidine Tablets USP 150mg
B) Ranitidine Tablets USP 300mg
B) Ranitidine Tablets USP 300mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A) Ranitidine Tablets USP 150mg
Each film coated tablet contains:
Ranitidine Hydrochloride USP
Equivalent to Ranitidine 150mg
Excipients q.s.
Colour: Ponceau 4 R
B) Ranitidine Tablets USP 300mg
Each film coated tablet contains:
Ranitidine Hydrochloride USP
Equivalent to Ranitidine 300mg
Excipients q.s.
Colour: Fast green FCF
Each film coated tablet contains:
Ranitidine Hydrochloride USP
Equivalent to Ranitidine 150mg
Excipients q.s.
Colour: Ponceau 4 R
B) Ranitidine Tablets USP 300mg
Each film coated tablet contains:
Ranitidine Hydrochloride USP
Equivalent to Ranitidine 300mg
Excipients q.s.
Colour: Fast green FCF
THERAPEUTIC INDICATIONS:
Ranitidine is a medication used to decrease stomach acid production. It is commonly used in treatment of peptic ulcer disease, gastroesophageal reflux disease, and Zollinger–Ellison syndrome.
CAUTION & WARNING:
CAUTION:
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
STORAGE & DOSAGE:
Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Protect from light and moisture.
Dosage: As directed by the Physician
Attach dispensing label as per end county.
Protect from light and moisture.
Dosage: As directed by the Physician
Attach dispensing label as per end county.