(and dosage form):
Each 2 mL ampoule contains ranitidine hydrochloride equivalent to Ranitidine 50 mg.
Phenol 0,5% m/v (as preservative)
A11.4.3 Medicines acting on gastro-intestinal tract. Antacids other.
Ranitidine is a selective and competitive histamine H2-receptor antagonist. It does not exhibit anti-serotonergic or histamine H1-receptor blocking activities. Ranitidine inhibits basal and stimulated secretion of gastric acid, reducing both the volume of secretions, the acid and pepsin content but does not affect gastric mucous secretion.
The elimination half-life of ranitidine is approximately 2-3 hours.
Ranitidine is excreted via the kidneys in the free and metabolised forms. Its major metabolite is the N-oxide with smaller quantities of S-oxide and desmethyl ranitidine.
R-LOC INJECTION is indicated for the treatment of duodenal ulcer, benign gastric ulcer, reflux oesophagitis and Zollinger-Ellison syndrome.
R-LOC INJECTION may also be used as pre-medication prior to anaesthesia in order to reduce the volume and acid content of gastric secretion, thereby minimising the consequence of the acid aspiration syndrome.
R-LOC INJECTION is contra-indicated in patients known to have hypersensitivity to any of the ingredients.
R-LOC INJECTION should be avoided in patients with a history of porphyria.
Treatment with R-LOC INJECTION may mask symptoms associated with carcinoma of the stomach and may, therefore, delay diagnosis of the condition. Accordingly where gastric ulcer is diagnosed the possibility of malignancy should be excluded before therapy with R-LOC INJECTION is instituted.
Because of R-LOC INJECTIONs documented ability to inhibit hepatic microsomal drug metabolism, elimination of other medications that require hepatic metabolism via the cytochrome (P450) system or that are highly extracted by the liver, may be decreased during concurrent use with R-LOC INJECTION.
Isolated cases of drug interactions have been reported between ranitidine and glipizide, glyburide, metoprolol, midazolam, nifedipine, phenytoin, theophylline, and warfarin.
Monitoring of blood concentrations or prothrombin time for anticoagulants as a guide to dosage is recommended since dosage adjustment of these medications may be necessary during and after ranitidine therapy to prevent bleeding due to anticoagulant potentiation.
Concurrent use of phenytoin may increase the risk of ataxia due to increased blood concentrations of phenytoin.
Renal elimination of procainamide may be decreased due to competition between ranitidine and procainamide for active tubular secretion, resulting in increased blood concentration of procainamide.
PREGNANCY AND LACTATION
The safety in pregnancy and lactation has not been established. R-LOC INJECTION crosses the placenta and is excreted in breast milk in lactating mothers. R-LOC INJECTION should not be administered to pregnant or nursing women.
DOSAGE AND DIRECTIONS FOR USE:
For intravenous or intramuscular injection.
Adults: R-LOC INJECTION may be given either as a slow (over two minutes) intravenous injection of 50 mg, diluted to a volume of 20 mL which may be repeated every 6-8 hours, or as an intravenous infusion at a rate of 25 mg per hour for two hours; the infusion may be repeated at 6-8 hour intervals.
For pre-medication prior to anaesthesia in order to reduce the volume and acid content of gastric secretion, R-LOC INJECTION should be given intramuscularly or by a slow intravenous injection (over two minutes) of 50 mg diluted to a volume of 20 mL, 45-60 minutes before induction of general anaesthesia.
R-LOC INJECTION has been shown to be compatible with the following intravenous infusion fluids:
0,9% Sodium Chloride BP and Dextrose 5% BP;
0,18% Sodium Chloride and 4% Dextrose BP;
4,2% Sodium Bicarbonate BP
Children: There has been no experience with R-LOC INJECTION in children.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Leucopenia, thrombocytopenia, agranulocytosis, pancytopenia (occasionally with bone marrow hypoplasia or aplasia). Incidence of these side-effects is rare.
Less frequent: Bradycardia, AV block.
Headache (sometimes severe), dizziness, mental confusion, depression, hallucinations (in the elderly and severely ill), involuntary motor disturbances. Incidence of these side-effects is rare.
Less frequent: Breast symptoms and gynaecomastia in men.
Less frequent or rare: Diarrhoea, nausea, vomiting, constipation.
Reversible and transient changes in liver function tests, hepatitis (hepatocellular, hepatocanalicular or both), with or without jaundice, acute pancreatitis. Incidence of these side-effects is rare.
Less frequent: Arthralgia, myalgia.
Less frequent or rare: Skin rash, vasculitis, erythema multiforme, alopecia.
Angioedema, bronchospasm, urticaria, fever, hypotension and anaphylactic shock. These reactions have occasionally occurred after a single dose.
Bradycardia in association with rapid administration of R-LOC INJECTION has been reported, usually in patients with factors predisposing to cardiac rhythm disturbances. Recommended rates of administration should not be exceeded.
R-LOC INJECTION is excreted via the kidneys thus plasma levels of the medicine are increased and prolonged in patients with severe renal impairment. It is therefore recommended that the dose be reduced to half the usual dose given daily as a single or divided dose. In the case of R-LOC INJECTION, it is recommended that in such patients doses of 25 mg are administered. Use of higher than recommended doses of intravenous H2-antagonists has been associated with rises in liver enzymes where treatment has been extended beyond five days.
Care should be taken to carry out periodic examinations of patients on prolonged maintenance treatment with ranitidine as a safeguard against the occurrence of unforeseeable consequences of drug treatment.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See "Side-effects and Special Precautions". Treatment is symptomatic and supportive as appropriate.
Ranitidine may be removed from the plasma by haemodialysis should it be required.
Clear, colourless to pale yellow solution free from fibres and particulate matter
5 x 2 mL clear flint glass ampoules in individual plastic holders inside an outer carton.
Store below 25°C, protected from light.
Do not refrigerate.
KEEP OUT OF REACH OF CHILDREN.
NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Zydus Healthcare SA (Pty) Ltd
Adrina Bldg, 1st Floor
Klinkenberg Street 32-34
Van Der Hoffpark
DATE OF PUBLICATION OF THIS PACKAGE INSERT:
12 January 2005
New addition to this site: January 2008
Source: Pharmaceutical Industry
SAEPI HOME PAGE
TRADE NAME INDEX
GENERIC NAME INDEX
Information presented by Malahyde Information Systems © Copyright 1996-2008