Rantin

Rantin

ranitidine

Manufacturer:

Kalbe Farma
Full Prescribing Info
Contents
Ranitidine HCl.
Action
Pharmacology: Ranitidine is a reversible competitive antagonist of histamine (H2) receptor in the parietal cells of gastric mucosa, therefore effectively inhibits gastric acid secretion. The bioavailability of ranitidine peroral is about 50%. Food or antacids do not influence significantly the absorption of ranitidine peroral. After 2-3 hours given 150 mg dose of ranitidine, the mean peak levels (Cmax average) is around 450-550 ng/mL. The elimination half-life (T1/2) is 2.5-3 hours, but serum concentration above the IC50 is reached up to 12 hours after a single oral dose of 150 mg ranitidine. Serum concentration that required to inhibit 50% (IC50) of gastric acid secretion is approximately 36-94 ng/mL. After single IM injection of 50 mg ranitidine, the mean peak levels (Cmax average) is around 576 ng/mL within 15 minutes or less. The elimination half-life (T1/2) is 2-2.5 hours, but serum concentration above the IC50 is reached until 6-8 hours after a single dose of 50 mg IM or IV ranitidine injection. Ranitidine is eliminated mainly by renal excretion.
Indications/Uses
1. Short treatment of active duodenal ulcer, active gastric ulcer, and to reduce the symptoms of esophagitis reflux.
2. Maintenance treatment after peptic ulcer and gastric ulcer recovery.
3. Treatment of various pathological hypersecretory conditions (e.g., Zollinger Ellison syndrome, Systemic Mastocytosis).
RANTIN injection are used for some hospitalized patients with those conditions or as an alternative treatment to the oral dosage form for short-term use in patients who are unable to take oral medication.
Dosage/Direction for Use
Adults, peroral. 1. Active duodenal ulcer: 150 mg b.i.d (in the morning and evening) or 300 mg once daily after dinner or before bedtime, for 4-8 weeks.
2. Active gastric ulcer: 150 mg b.i.d. (in the morning and evening) for 2 weeks.
3. Maintenance therapy of duodenal and gastric ulcer recovery: 150 mg before bedtime.
4. Pathological hypersecretory conditions (e.g. Zollinger Ellison syndrome, Systemic Mastocytosis): Start with 150 mg b.i.d; the period of treatment is depend on the clinical symptoms. The dose may be increased according to individual patient needs (up to 6 g/day in divided doses).
5. Gastroesophageal reflux: 150 mg b.i.d.
6. Erosive oesophagitis: 150 mg q.i.d.
7. Maintenance and erosive oesophagitis recovery: 150 mg b.i.d. Concomitant antacids should be given as needed in order to relief the pain (antacids does not significantly influence the absorption of RANTIN peroral).
Adults, injection given IM injection: 50 mg (2 mL) every 6-8 hours. (Dilution is not necessary).
IV infusion: intermittent.
1. Intermittent bolus: 50 mg (2 mL) every 6-8 hours. RANTIN injection 50 mg is diluted in NaCL 0.9% or other compatible IV solution until the concentration is not more than 2.5 mg/mL (volume total 20 mL). The rate of injection is not more than 4 mL/minute (during 5 minutes).
2. Intermittent infusion: 50 mg (2 mL) every 6-8 hours. RANTIN injection 50 mg is diluted in Dextrose 5% solution or other compatible IV solution until the concentration is not more than 0.5 mg/mL (volume total 100 mL). The rate of infusion is not more than 5-7 mL/minute (during 15-20 minutes).
3. Continuous IV infusion: RANTIN injection 150 mg is diluted in 250 mL Dextrose or other compatible IV solution and is given with infusion rate of 6.25 mg/hour during 24 hours. For Zollinger Ellison syndrome patient or other hypersecretion conditions, RANTIN injection must be diluted with Dextrose 5% solution or other compatible IV solution until the concentration is not more than 2.5 mg/mL. The rate of infusion is starting from 1 mg/kg BW/hour, and must be adjusted depending on the patient condition.
When higher dosage is necessary, the increase should be made by more frequent administration of a 50 mg dose, but generally should not exceed 400 mg per day.
Dosage in impaired renal function If creatinine clearance <50 mL/minute: 150 mg/24 hours (every 12 hours or more frequent if necessary). Since ranitidine is removed by haemodialysis, the timing of the dosage schedule should be adjusted to coincide with the end of haemodialysis.
Overdosage
Overdosage symptoms which have been reported (in oral administration of more than 18 gram of ranitidine has been associated with transient adverse effects) such as: acute abdominal disturbances, hypotension, and abnormalities of gait.
Overdosage treatment: Induce emesis or gastric lavage.
Acute attack: diazepam IV injection.
Bradycardia: atropine.
Arrhythmia: lidocaine.
Contraindications
Hypersensitivity to ranitidine.
Special Precautions
Gastric malignancy: May give symptomatic response to ranitidine, therefore will delay the diagnosis of this condition. Impaired renal function: adjust the dosage (ranitidine is eliminated primarily by the kidney). Hepatic dysfunction: use with caution (ranitidine is metabolized in the liver). Unlike cimetidine, ranitidine at recommended dosage does not inhibit the hepatic metabolism of warfarin, phenytoin, theophylline, and other drugs. Avoid given in patients with history of acute porphyria. The recovery time and side effect in elderly are different with the adult patients.
Use in pregnancy & lactation: Use only if considered essential (animal studies have revealed no evidence of teratogenicity, but there are no adequate and well controlled studies in pregnant women). Ranitidine is secreted in human milk.
Use in children: Effectiveness and safety in pediatric patients have not been established. 
Use In Pregnancy & Lactation
Use only if considered essential (animal studies have revealed no evidence of teratogenicity, but there are no adequate and well controlled studies in pregnant women). Ranitidine is secreted in human milk.
Adverse Reactions
Headache.
Central nervous system: Malaise, dizziness, somnolence, insomnia, vertigo, agitation, depression, and hallucination are rare.
Cardiovascular system: Arrhythmia, such as tachycardia, bradycardia, atrioventricular premature block ventricular beats.
Gastrointestinal: Constipation, diarrhoea, nausea, vomiting, abdominal pain, rare: pancreatitis.
Musculoskeletal: Arthralgia and myalgia.
Haematologic: Leucopenia, granulocytopenia, thrombocytopenia, (in some patients) agranulocytopenia, pancytopenia, trombocytopenia, aplastic anemia, have been eported.
Endocrinologic: Gynecomastia, impotence, and loss of libido have been reported in male patient.
Dermatologic: Rash, multiform erythematous, alopecia.
Others: Hypersensitivity case is rare (example: bronchospasme, fever, eosinophilia), anaphylactic, angioneurotic oedem, small increases in creatinine serum concentration.
Drug Interactions
Ranitidine does not inhibit the action of cytochrome P450. Concomitant with warfarine can increase or decrease the prothrombine time.
Storage
Store below 25°C.
Ampoule: Protect from light.
RANTIN injection is stable for 48 hours at room temperature when added to or diluted with most commonly used IV solution, e.g.: 0.9% Sodium chloride injection, 0.5% Dextrose injection, 10% Dextrose injection, Lactate Ringers solution, or 5% Sodium bicarbonate injection.
ATC Classification
A02BA02 - ranitidine ; Belongs to the class of H2-receptor antagonists. Used in the treatment of peptic ulcer and gastro-oesophageal reflux disease (GERD).
Presentation/Packing
Tab 150 mg x 10 x 10's. Inj (amp) 50 mg/2 mL x 5's.
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