Ranitidine as Hydrochloride (Ranitein) 25mg/ml Solution for Injection I.M/I.V 2ml x Ampoules 10's

Product Description:

Ranitidine as Hydrochloride (Ranitein) 25mg/ml Solution for Injection I.M/I.V 2ml x 10's is a histamine H2 receptor antagonist. It works by blocking the action of histamine on the H2 receptors in the stomach, thereby reducing stomach acid production. Ranitidine is used for various acid-related gastrointestinal conditions, including ulcers and gastroesophageal reflux disease (GERD).

Each 2ml ampoule contains 25mg of Ranitidine hydrochloride, which is administered via intramuscular (I.M.) or intravenous (I.V.) injection. This formulation provides a rapid onset of action and is often used in hospital settings when oral administration is not possible.

Indications:

Ranitidine (Ranitein) 25mg/ml Solution for Injection is indicated for the following conditions:

1. Peptic Ulcers:

   • Treatment and prevention of gastric and duodenal ulcers.

   • Healing of gastric ulcers associated with NSAID (nonsteroidal anti-inflammatory drug) use.

2. Gastroesophageal Reflux Disease (GERD):

   • Management of symptoms such as heartburn and regurgitation caused by acid reflux.

3. Zollinger-Ellison Syndrome:

   • A condition in which the stomach produces excessive amounts of acid.

4. Prevention of Aspiration Pneumonitis:

   • Used before surgery to reduce stomach acid production and the risk of aspiration pneumonia due to inhalation of gastric contents.

5. Stress Ulcers:

   • Prophylactic treatment in critically ill patients to prevent stress-related ulcers.

6. Upper GI Bleeding:

   • To reduce the secretion of stomach acid and promote the healing of ulcers in patients with upper gastrointestinal bleeding.

Dosage:

The dose of Ranitidine (Ranitein) will depend on the specific condition being treated and the individual patient's clinical situation. Below is a general dosage guide:

For Adults:

• Peptic Ulcers:

  • Initial dose: 50 mg every 6 to 8 hours by intravenous injection (I.V.) or intramuscular injection (I.M.).

  • For severe cases or in patients unable to take oral medication, the dose may be adjusted as necessary, generally up to 100 mg every 8 hours.

• Gastroesophageal Reflux Disease (GERD):

  • 50 mg every 6-8 hours by I.V. or I.M. injection.

• Zollinger-Ellison Syndrome:

  • Higher doses may be used, typically 100 mg every 6 hours, but the dose may be adjusted based on the patient's clinical response.

• Prevention of Aspiration Pneumonitis:

  • 50 mg intravenously 1 hour before anesthesia induction.

• Stress Ulcers:

  • 50 mg every 6 to 8 hours by I.V. or I.M. injection.

• Upper GI Bleeding:

  • The dose may vary depending on severity, but typical dosing is 50 mg every 6 to 8 hours via I.V. or I.M. injection.

For Pediatric Patients:

• The dosing for children is based on the weight and age of the child. The dosage should be adjusted by the healthcare provider.

Administration:

• Intravenous (I.V.) Injection: Administer over 2 minutes.

• Intramuscular (I.M.) Injection: Can be injected into the muscle as directed.

Side Effects:

Common side effects of Ranitidine (Ranitein) include:

• Headache.

• Dizziness.

• Constipation or diarrhea.

• Abdominal discomfort.

• Nausea or vomiting.

• Fatigue.

More serious side effects may include:

• Severe allergic reactions: Symptoms may include rash, itching, swelling of the face, lips, or throat, and difficulty breathing.

• Arrhythmias (irregular heartbeat), especially with higher doses.

• Liver dysfunction: Symptoms may include yellowing of the skin or eyes (jaundice), dark urine, or unexplained fatigue.

• Severe dizziness or confusion.

• Blood dyscrasias: Rarely, Ranitidine may cause changes in blood cells, leading to low white blood cells, low platelets, or anemia.

• Severe abdominal pain: This could indicate pancreatitis or other serious digestive issues.

If any of these severe side effects occur, seek immediate medical attention.

Contraindications:

Ranitidine (Ranitein) should not be used in the following conditions:

• Hypersensitivity or allergy to Ranitidine or any of its components.

• Severe liver impairment: Caution should be used, and dose adjustments may be necessary for patients with liver disease.

• Acute porphyria: Ranitidine may precipitate a porphyric crisis in patients with this rare genetic disorder.

• Renal impairment: In patients with severe renal impairment, the dose should be reduced to avoid potential accumulation and side effects.

Pregnancy and Breastfeeding:

• Pregnancy: Ranitidine is classified as a category B drug during pregnancy, meaning it is considered safe for use during pregnancy based on animal studies, but should be used only if clearly needed and prescribed by a healthcare provider.

• Breastfeeding: Ranitidine passes into breast milk in small amounts. If used during breastfeeding, the potential benefits should be weighed against the risks. Always consult a healthcare provider before using this medication while breastfeeding.

Precautions:

• Renal Impairment: Caution is advised when administering Ranitidine to patients with renal dysfunction. In these patients, the dose may need to be reduced or adjusted to prevent drug accumulation.

• Liver Disease: As Ranitidine is metabolized by the liver, caution is advised in patients with liver disorders. Dosage adjustments may be required.

• Cardiovascular Disease: In patients with heart conditions, particularly those with a history of arrhythmias, Ranitidine should be used cautiously, especially at high doses.

• Older Adults: Older individuals may be more susceptible to the side effects, especially dizziness, confusion, and low blood pressure. Monitoring is recommended during treatment.

• Drug Interactions: Ranitidine may interact with other medications, including warfarin, phenytoin, and theophylline, potentially affecting their effectiveness or increasing the risk of side effects. Always inform the doctor of other medications being taken.

Important Note: Ranitidine (Ranitein) should be used under the guidance of a healthcare provider, especially when administered via injection, as it is typically used for acute or severe conditions that require rapid acid suppression. Ensure that the correct dosage and administration route are followed to avoid complications.

If you experience any persistent or unusual symptoms, or if you believe you have received too much medication, contact your healthcare provider immediately.