Ranitidine 2 ml. 10 ampoules

SOPHARMA
Ranitidine 2 ml. 10 ampoules
€ 29.00
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QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ampoule with 2 ml contains drug Ranitidine hydrochloride in amount 56 mg, equivalent to Ranitidine 50 mg.
 
 
3. PHARMACEUTICAL FORM
Solution for injection
 
 
4. CLINICAL DATA
 
4.1. Indications:
• For short-term treatment of gastric, duodenal ulcers and postoperative. which are difficult to oral therapy or it is impossible;
• Prevention of stress ulcers and gastrointestinal stress duodenal erosions in patients in serious condition;
• Prevention of recurrent gastrointestinal bleeding in patients with bleeding peptic ulcers in critical condition;
• Prevention of gastrointestinal bleeding from stress ulcers in severely ill patients;
• Before induction of general anesthesia at risk of acid aspiration syndrome during surgery.
 
 
4.2. Dosage and method of administration
Method of administration:
intramuscularly or intravenously.
Ranitidine injection is compatible with these infusion solutions: 0.9% sodium chloride solution, 5% dextrose solution, 0.18% sodium chloride and 4% dextrose, 4.2% sodium bicarbonate; Hartmann's solution. Intramuscular: 50 mg (2 ml) every 6 to 8 hours.
 
Intravenous:
In the form of bolus injection: 50 mg (2 ml) solution for injection to a volume of 20 ml and is introduced slowly for 2 min. Infusion: The injection solution was diluted with 5% dextrose solution or other compatible solutions and are administered intravenously, drip a rate of 25 mg / h for 2 hours. If necessary, place the reintroduction of intervals of 6 to 8 hours. The maximum daily dose is no more than 400 mg.
For prevention of recurrent gastrointestinal hemorrhage in patients with peptic ulcers is critical: In the form of bolus injection is administered 50 mg (2 ml) slowly intravenously followed by intravenous infusion at 0,125 - 0,250 mg / kg / h.
For the prophylaxis of gastrointestinal haemorrhage in severe patients with stress ulcers: Initial dose of 50 mg intravenously, slowly, followed by infusion at a rate from 0.125 to 0, 25 mg / kg / h.Pri risk of acid aspiration syndrome during general anesthesia, 50 mg - i. m. or slow i. v. 45 to 60 min prior to anesthesia. Patients over 65 years of age: 25 mg daily iv or i.m. Patients with renal insufficiency: The recommended daily dose in patients with creatinine clearance <50 ml / min is 25 mg iv or i.m. Hemodialysis reduced circulating levels of ranitidine, which is why it is administered at the end of dialysis.
Patients with hepatic dysfunction {compensated cirrhosis): No adjustment of dosage.
Children: pediatric ranitidine injection is not applied due to lack of clinical trials.
 
4.3. Contraindications
Hypersensitivity to the drug or to any of the excipients.
 
 
4.4. Special warnings and precautions
• Before therapy with ranitidine is necessary to exclude the possibility of the presence of malignancy. Treatment with ranitidine may mask symptoms associated with a malignant process and delay diagnosis.
• Since ranitidine is excreted primarily by the kidney, patients with evidence of renal insufficiency have an adjustment of dose and dosing interval. With consideration given to patients with liver dysfunction because his metabolism occurs primarily in the liver.
"In rare cases, the use of ranitidine lead to acute porphyria. In a history of acute porphyria avoid therapy with ranitidine.
• The content of sodium as an excipient in injection may be dangerous for patients hyponatraemic diet.
• The presence of potassium as an excipient may be a danger to patients hypokalemic diet and in rare cases cause pain at the injection site or phlebitis.
• Para-hydroxybenzoates present in the composition of ranitidine injection can rarely cause in patients hypersensitive to these effects of delayed-type hypersensitivity and often bronchospasm.
• It should not exceed the recommended rate of administration due to the risk of bradycardia. If there is a predisposition in some patients may appear abnormal heart rhythm. The recommended dose should not be exceeded.
 
 
4.5. Interactions
Ranitidine does not inhibit microsomal liver enzymes and therefore do not affect the action of diazepam, phenytoin, propranolol, theophylline, warfarin, acenocoumarol and similar products which are metabolized by the action of these enzymes.
 
4.6. Use in pregnancy and lactation
There is no evidence of teratogenic properties in studies of ranitidine in rats and rabbits at doses 160-fold above the human therapeutic range. No controlled studies performed on pregnant women. Ranitidine is secreted in the milk of nursing mothers. In this connection, not recommended for use in pregnant and breast-feeding.
 
4.7. Effects on ability to drive and use machines
Does not have adverse effects on the ability to drive and use machines.
 
 
4.8. Undesirable effects
Ranitidine is usually well tolerated. Side effects may be: Cardiovascular System (1010) - as with other H2-blockers, rare but can occur tachycardia, bradycardia and beats; in very rare cases, AV, block and asystole.
CNS (0410) - in rare cases - headache (occasionally severe), dizziness, somnolence, insomnia and vertigo; very rarely observed confusion, agitation, anxiety and hallucinations (in severely ill patients or elderly patients), involuntary movement disorders. Sensory organs (0431) - are possible cases of reversible blurred vision caused by accommodation disorders.
Gastrointestinal system (0600) - nausea, vomiting, constipation, stomach discomfort, combined with pain; rare reports of acute pancreatitis. Skin and appendages (0100) - Rash, including rare cases of erythema multiforme; izkyuchitelno rarely alopecia and vasculitis.
Hepatobiliary system (0700) - rarely - hepatocellular, cholestatic or mixed hepatitis with or without jaundice. In these cases ranitidine therapy be discontinued. In very rare cases ranitidine can cause liver failure.
Heshtologichni and homeostasis disorders (1210, 1220, 1230) granulocytopenia, leukopenia, thrombocytopenia, which are usually transient.
 In rare cases are possible agranulocytosis, pancytopenia (sometimes with bone marrow hypoplasia) and aplastic anemia. Incidental causes of acquired immune hemolytic anemia.
Respiratory system (1100) - flu-like symptoms, rhinitis, cough, rarely - pneumonitis, respiratory distress.
Musculoskeletal system (0200) - Rare cases of arthralgia and myalgia. Metabolic and electrolyte disturbances (0800) - ranitidine had no stimulating effect on the hormones of the pituitary and no anti-androgenic activity. In very rare cases can cause gynecomastia, impotence and loss of libido in men. Causal link between these disorders and taking ranitidine so far not been proven definitively.
Other: Rare cases of hypersensitivity reactions (experienced bronchospasm, fever, rash, eosinophilia), angioneurotic edema; slight increase in serum kreatinin.Na application site (1820): transient pain at the injection site; transient warming and itching in intravenous administration.
 
 
4.9. Overdose
Specific symptoms of overdose have not been established, but may occur: headache, nausea, vomiting, bradycardia, hypotension; in very rare cases, confusion, depression. Held symptomatic and supportive lechenie.Ranitidin can be removed from the plasma by hemodialysis.
 
 
5. PHARMACOLOGICAL
ATC code-A02B A02
Pharmacotherapeutic group:
Drugs for the treatment of peptic ulcer. H2 -receptor antagonists.
 
 
5.1. Pharmacodynamic properties
Ranitidine is an effective, fast-acting, a competitive, reversible inhibitor of histamine receptors Ng. Inhibits basal and stimulated by histamine, pentagastrin and food secretion of hydrochloric acid. Reduces the amount of gastric juice secreted and its acid and pepsin content. Almost no effect on the concentration of gastrin in plasma, of the secretory activity of the pancreas and the production of mucus. Ranitidine is 7 times more active than cimetidine as an inhibitor of induced histamine secretion in vivo experiments (perfusion of the stomach of anesthetized rats). Ranitidine has expressed anti-ulcer activity in various models of experimental ulcerative disabilities. Does not have an inhibitory effect on cytochrome R45o-oxygenase enzymes associated mixed function in the liver. In experiments on narcotized dogs intravenous ranitidine at a dose of 1 mg / kg t. M. Not cause significant changes in the basic hemodynamic parameters.
 
 
5.2. Pharmacokinetic Properties
Absorption - ranitidine is absorbed very quickly after intramuskulio injection. The peak plasma concentration of 576 ng / ml was reached after 15 or less minutes after a single intramuscular dose of 50 mg. The absolute bioavailability of ranitidine after intramuscular injection is 90 to 100% and compared to that following intravenous administration. Serum concentrations necessary for inhibition of 50% of the stimulated gastrointestinal acid secretion are within the range of 36 to 94 ng / ml. Following a single intramuscular or intravenous dose of 50 mg, serum concentrations were within this range for 6 to 8 hours.
Distribution - binds to plasma proteins on average by 15%. The volume of distribution is 1.4 I / kg.Metabolizira in the liver, has a pronounced first-pass effect. Excretion - after intravenous bolus injection, approximately 70% of the dose was excreted in urine unchanged. Renal clearance averaged 530 ml / min with a total clearance of 760 ml / min. The half-life (t 1/2) is approximately 2 to 2.5 hours.
 
 
5.3. Preclinical safety data
Acute toxicity (LD50)
The calculated median lethal dose (LD50) following intravenous administration to mice and rats is 77 and 83 mg / kg respectively.
In a single intramuscular administration in mice LD5o is 443 (392 -501) mg / kg t. M., And rats - LD50 is 3000 mg / kg t. M.
Sub-acute (30 day) toxicity
Subacute toxicity was performed on Wistar rats of both sexes equally treated intramuscularly with doses of 50 and 25 mg / kg. Clinical laboratory and post-mortem studies have shown no evidence of toxic changes in the conditions of eksperiment.Izsledvaniya held on reproduction have been conducted in rats and rabbits. There is no evidence of impaired fertility or fetal doses in excess of 160 times the human therapeutic range.
In carcinogenicity studies conducted in mice and rats revealed no significant differences in the induction of tumors in experimental animals and control groups at doses exceeding 2000 mg / kg. Data from the carcinogenicity studies showed no risk to humans
 
 
6. PHARMACEUTICAL PARTICULARS
6.1. List of excipients
 
Potasium dihydrogen phosphate; Disodium phosphate dihydrate; Methyl parahydroxybensoate; Propyl parahydroxybensoate; Water for injection.
 
 
6.2. Incompatibilities
He established.
 
6.3. Shelf life
Three (3) years.
 
6.4. Special storage conditions
In original container, dry and protected from light at a temperature below 25 ° C.
Do not freeze! Keep out of reach of children!
 
6.5. Packaging Data
Primary packaging
Injection of 50 mg / 2 ml ampoules in colorless transparent glass I - you hydrolytic class.
 
 
Secondary packaging
10 (ten) ampoules in rigid PVC blister foil, by (1) or one (10) ten blister in boxes with flyers.
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