Clinical-pharmacological group
11.001 Blocker (histamine H2-receptors. Antiulcer drug)
In the beginning of
Form of production, composition and packaging
Coated tablets white, round, convexoconvex, engraved with "GX EC2" on the one hand.

1 tab.
ranitidine (in the form of hydrochloride) 150 mg
Excipients: microcrystalline cellulose, magnesium stearate, methylhydroxypropylcellulose, titanium dioxide, triacetin.

10 pcs. - Blisters (2) - packs cardboard.

Tablets, film-coated white, oval, convexoconvex, engraved with "GX EC3" on the one hand.

1 tab.
ranitidine (in the form of hydrochloride), 300 mg
Excipients: microcrystalline cellulose, magnesium stearate, croscarmellose sodium, methylhydroxypropylcellulose, titanium dioxide, triacetin.

10 pcs. - Blisters (1) - packs cardboard.

Effervescent tablets round, flat, with bevelled edges, from light-yellow to almost white.

1 tab.
ranitidine (in the form of hydrochloride) 150 mg
Excipients: sodium monotsitrat anhydrous, sodium hydrocarbonate, aspartame, povidone K30, sodium benzoate, orange flavor, grapefruit flavour (sodium content 14.3 of the Iec (328 mg) / 1 tab.)

6 pcs. - Blisters aluminium (1) - packs cardboard.
6 pcs. - Blisters) aluminium (2) - packs cardboard.
10 pcs. - Blisters aluminium (1) - packs cardboard.
10 pcs. - Blisters) aluminium (2) - packs cardboard.
15 pcs. - Polypropylene tubes (1) - packs cardboard.

Effervescent tablets round, flat, with bevelled edges, from light-yellow to almost white.

1 tab.
ranitidine (in the form of hydrochloride), 300 mg
Excipients: sodium monotsitrat anhydrous, sodium sodium, aspartame, povidone K30, sodium benzoate, orange flavor, grapefruit flavour (sodium content 20.8 Iec (479 mg) / 1 tab.).

6 pcs. - Blisters aluminium (1) - packs cardboard.
6 pcs. - Blisters) aluminium (2) - packs cardboard.
10 pcs. - Blisters aluminium (1) - packs cardboard.
10 pcs. - Blisters) aluminium (2) - packs cardboard.
15 pcs. - Polypropylene tubes (1) - packs cardboard.

Solution for injection is a clear colorless or light-yellow colour.

1 ml of 1 amp.
ranitidine (in the form of hydrochloride) 25 mg, 50 mg
Excipients: sodium chloride, potassium digidroortofosfat, sodium gidroortofosfat dibasic anhydrous, nitrogen, water d / and.

2 ml ampoule (5) - packs cardboard.

In the beginning of
Pharmacological action
Blocker histamine H2-receptors. Decreases basal and stimulirovannuyu irritation of the baroreceptors, food processing activity, the action of histamine, gastrin and other biogenic stimulators secretion of hydrochloric (hydrochloric acid).

Decreases as the volume of the secret, and the contents in it of hydrochloric (hydrochloric acid and pepsin. Helps to increase the Ph of gastric contents, which leads to a decrease in the activity of pepsin. The duration of ranitidine after a single reception - 12 hours.

Helicobacter pylori is defined in approximately 95% of patients with ulcers duodenal ulcer and in 80% of patients with ulcers of the stomach. When combined ranitidine with amoxicillin and metronidazole in about 90% of cases is observed eradikation Helicobacter pylori. This combination of drugs significantly reduces the frequency of exacerbations of peptic ulcer of the duodenum.

In the beginning of
The Pharmacokinetics Of
Absorption

The ingestion bioavailability of ranitidine is about 50%. After intake of the drug in the dose of 150 mg Cmax is achieved in 2-3 hours and is 300-550 ng / ml.

After the on / m introduction Cmax is achieved within 15 min after the introduction and is 300 to 500 ng / ml.

The Distribution Of

Tying with the plasma protein does not exceed 15%. Ranitidine penetrates through the placental barrier. Excreted in the breast milk (concentration in breast milk is higher than in plasma). Poor permeates through GEB.

Metabolism

Not metabolizmu. The metabolism of ranitidine no different parenteral introduction and the ingestion and proceeds with the formation of small amounts of N-oxide (6%), the S-oxide (2%), desmetilranitidina (2%) and analogue furoevoy acid (1-2 %).

Excretion

T1 / 2 is 2-3 hours.

After reception of 3H-ranitidine in the dose of 150 mg 60-70% of the drug is excreted with urine and 26% - with faeces; and 35% of the dose is excreted with urine in an unmodified form.

After the on / in the introduction of 3H-ranitidine in the dose of 150 mg 93% of the drug excreted in the urine and 5% from faeces; in the first 24 hours 70% of the dose is excreted with urine in an unmodified form .

Pharmacokinetics in special clinical cases

When expressed violations of the kidneys concentration of ranitidine in the plasma increases.

In the beginning of
Dosage
Pills and effervescent tablets

Inside adult for acute duodenal ulcer diseases and benign gastric ulcers is administered 150 mg 2 times / day or 300 mg per night. In most cases, ulcers of the duodenum and benign gastric ulcers heal within 4 weeks. In patients with unhealed during this period ulcers healing usually occurs on a background of continuing treatment during the next four weeks. In the treatment of ulcers of the duodenum reception of the drug in the dose of 300 mg 2 times / day is more effective than receiving doses of 150 mg 2 times / day or 300 mg 1 time per night. Increasing doses does not lead to an increase in the frequency of side effects.

When long term prevention of the recurrence of duodenal ulcers and stomach appoint 150 mg 1 time / day (at night). For smokers patients more preferable to increase the doses up to 300 mg per night (because smoking is associated with a higher frequency of recurrence of ulcers).

For treatment of ulcers associated with the admission NPVS, appoint 150 mg 2 times / day or 300 mg per night for a period of 8-12 weeks, for the prevention of 150 mg 2 times / day during treatment with NSAIDS.

For the treatment of duodenal ulcers associated with Helicobacter pylori, appoint 150 mg two times a day (morning and evening), or 300 mg 1 time / day (at night) in combination with amoxicillin at a dose of 750 mg 3 times / day) and metronidazole 500 mg 3 times / day for 2 weeks. Zantac Treatment should continue for the next two weeks. This scheme significantly reduces the frequency of the recurrence of duodenal ulcers.

In the postoperative ulcers administered 150 mg 2 times / day for 4 weeks. In patients with unhealed during this period ulcers healing usually occurs on a background of continuing treatment during the next four weeks.

In gastroesophageal reflux disease for the treatment of acute reflux-esophagitis is administered 150 mg 2 times / day or 300 mg per night for eight weeks; if necessary, the treatment course can be extended to 12 weeks. If moderate and severe reflux esophagitis, the dose may be increased to 150 mg 4 times / day with treatment duration up to 12 weeks. In carrying out preventive therapy with reflux-esophagitis recommended dose is 150 mg 2 times / day.

For relief of pain syndrome in gastroesophageal reflux disease appoint 150 mg 2 times / day for 2 weeks. In case of insufficient effectiveness of the treatment can be continued in the same dose over the next two weeks.

Zollinger-Ellison initial dose is 150 mg three times / day, if necessary dose can be increased. Doses of up to 6 g / day was well tolerated.

In chronic episodes of dyspepsia Zantac administered 150 mg 2 times / day for 6 weeks. In the case of the absence of a positive effect of the treatment, as well as in case of deterioration of the treatment should conduct a thorough examination.

For the prevention of bleeding from stress ulceration in seriously ill patients, as well as for the prevention of recurrent bleeding from peptic ulcer after the patient will be able to take food through the mouth, parenteral application of Zantac you can replace the appointment of the drug inside, in the dose of 150 mg 2 times / day.

For the prevention of syndrome Mendelssohn appoint Zantac in the dose of 150 mg in 2 hours before anesthesia, and also, preferably, 150 mg on the eve in the evening. It is possible parenteral application of Zantac.

For the prevention of syndrome Mendelssohn mothers during childbirth appoint 150 mg every six hours, but in case you want a general anesthesia, so before it should at the same time with Zantac use of water-soluble antacids (for example, sodium citrate).

Children for the treatment of peptic ulcer recommended dose of 2-4 mg / kg two times a day; maximum daily dose of 300 mg.

In patients with severe degree of renal insufficiency (CREATININE less than 50 ml / min) notes accumulation and increase the plasma concentration of ranitidine. The recommended dose is 150 mg one time / day.

Patients who are on long-term ambulatory peritoneal dialysis or on long-term hemodialysis, the preparation is administered in a dose of 150 mg immediately after the end of the dialysis session.

Solution for injection may be administered in the form of:

- Slow (more than 2 min), in / in the injection at a dose of 50 mg, which is diluted to a volume of 20 ml is injected every 6-8 hours;

- Intermittent on / in infusion at a rate of 25 mg / h for a period of two hours, with the re-introduction after 6-8 hours;

- In the / m injections in the dose of 50 mg every 6-8 hours.

For the prevention of bleeding from the stress of recurrence of ulcers and bleeding from peptic ulcer in critically ill patients Zantac administered in an initial dose of 50 mg in the form of a slow in / in the injection, and then spend long in / in infusion with a speed of 0.125-0.250 mg / kg / h. Parenteral therapy is continued until the patient is able to eat. Further it is possible to switch to the reception Zantac inside.

For the prevention of syndrome Mendelssohn the recommended dose is 50 mg in / m or slowly in / in for 45-60 minutes before anesthesia.

Patients with renal insufficiency in quantity of ciratinine less than 50 ml / min, the recommended dose of Zantac for parenteral administration of 25 mg.

In the beginning of
Overdose
Symptoms: convulsions, aetiology, jeludockove arrhythmia.

Treatment: symptomatic therapy is conducted; in the development convulsing - diazepam in / in, in bradikardii and ventricular arrhythmias - imposed atropine, lidocaine. Ranitidine may be removed from the plasma by hemodialysis.