Famotidine lyophilisate for the preparation of a solution for intravenous administration 20mg, No. 5

The drug Famotidine lyophilisate for the preparation of a solution for intravenous administration is indicated for the following diseases:

- duodenal ulcer;

- stomach ulcer without malignancy;

- gastroesophageal reflux disease;

- other conditions accompanied by hypersecretion (for example, Zollinger-Ellison syndrome);

- Prevention of aspiration of acidic stomach contents (Mendelssohn's syndrome during general anesthesia.

The drug Famotidine lyophilisate for the preparation of a solution for intravenous administration is intended only for intravenous administration. The drug Famotidine lyophilisate for the preparation of a solution for intravenous administration is recommended for use in inpatients who cannot take the drug inside. The drug Famotidine lyophilisate for the preparation of a solution for intravenous administration can be used until oral therapy becomes possible.

In case of duodenal ulcer, gastric ulcer without malignancy of gastroesophageal reflux disease :

The recommended dose is 20 mg intravenously twice a day (every 12 hours).

With Zollinger-Ellison syndrome :

The starting dose is 20 mg intravenously every 6 hours.

Further: the dose of the drug depends on the volume of secretion and the clinical condition

the patient.

With general anesthesia, to prevent aspiration of acidic stomach contents :

Famotidine is used in a dose of 20 mg on the morning of the operation or at least 2 hours before the start of the operation.

A single dose for intravenous administration may not exceed 20 mg. For intravenous injection, the contents of the vial should be dissolved in 5-10 ml of 09% sodium chloride solution (solvent ampoule) and then slowly injected (for at least 2 minutes). The prepared injection solution can be stored for 8 hours at room temperature.

If the drug is administered by infusion, the duration of the infusion should be 15-30 minutes. Solutions should be prepared immediately prior to administration. The following compatible solutions are recommended for dilution:

- glucose solution 5% (valid for 5 hours);

- Ringer's solution (valid for 8 hours);

- Ringer's lactate solution (valid for 8 hours);

- sodium chloride solution 09% is usable within 8 hours.

Only clear, colorless solutions can be used.

Application for renal failure :

Since famotidine is excreted primarily by the kidneys in patients with severe renal impairment, precautions must be taken. If creatinine clearance is less than 30 ml / min and serum creatinine concentration exceeds 3 mg / 100 ml, then the daily dose should be reduced to 20 mg or the intervals between injections should be increased to 36-48 hours.

Use in children and adolescents under 18 years of age :

The safety and efficacy of the drug in children and adolescents under 18 years of age have not been established.

Use in elderly patients (over 65 years old) :

No dose adjustment depending on age is required.

The lyophilisate bottle contains:

Active ingredient: famotidine 20 mg.

Excipients: aspartic acid 8.8 mg, mannitol 44 mg.

Ampoule with solvent contains:

sodium chloride 45 mg, water for injection up to 5 ml.

• Hypersensitivity to the active substance or any of the excipients,

• pregnancy

• breastfeeding period

• children under 18 years of age.

Carefully:

Hepatic and / or renal failure liver cirrhosis with portosystemic encephalopathy (in history) immunodeficiency hypersensitivity to H2-histamine receptor blockers (cross-hypersensitivity is possible).

Trade name of the drug

Famotidine

International non-proprietary name

Famotidine

Dosage form

lyophilisate for preparation of solution for intravenous administration

Composition

The lyophilisate bottle contains:

Active ingredient: famotidine 20 mg.

Excipients: aspartic acid 8.8 mg, mannitol 44 mg.

Ampoule with solvent contains:

sodium chloride 45 mg, water for injection up to 5 ml.

Description

Lyophilisate: White or off-white porous mass. Clumping is allowed.

Solvent: Clear, colorless solution.

Pharmacotherapeutic group

An agent that lowers the secretion of gastric glands - H2-histamine receptor blocker

ATX code

A02BA03

Pharmacodynamics:

Famotidine is a potent competitive inhibitor of histamine H2 receptors.

The main clinically significant pharmacological action of famotidine is inhibition of gastric secretion. Famotidine reduces both the concentration of hydrochloric acid and the volume of gastric secretion, while changes in the secretion of pepsin occur in proportion to the secreted volume.

In healthy volunteers and patients with hypersecretion, famotidine inhibits the basal and nocturnal secretion of hydrochloric acid and pepsinogen, as well as the secretion stimulated by the administration of pentagastrin betazol caffeine insulin and the physiological reflex of the vagus nerve. The duration of inhibition of secretion when using doses of 20 mg and 40 mg both after intravenous administration and after oral administration is from 10 to 12 hours, while a single evening application of the drug inhibits the basal and nocturnal secretion of hydrochloric acid. Famotidine has virtually no effect on fasting or postprandial serum gastrin concentration.

Famotidine has no effect on gastric emptying; exocrine pancreatic function; blood flow in the liver and portal system. Famotidine has no effect on the cytochrome P450 enzyme system in the liver. The antiandrogenic effect of the drug was not observed. Serum hormone levels did not change after famotidine treatment.

Pharmacokinetics:

Famotidine kinetics is linear.

Suction. The drug is intended for intravenous administration only.

Distribution

Plasma protein binding is relatively weak (15-20%). The elimination half-life is 23 - 35 hours. In patients with severe renal impairment, the elimination half-life of famotidine may exceed 20 hours.

Metabolism

Famotidine metabolism occurs in the liver. The only metabolite found in humans is sulfoxide.

Withdrawal

Famotidine is excreted by the kidneys (65-70%) and by metabolism (30-35%). Renal clearance is 250-450 ml / min, indicating some degree of tubular excretion. 65 - 70% of the intravenously administered dose is found unchanged in the urine. A small portion of the administered dose may be excreted in the form of sulfoxide.

Indications:

The drug Famotidine lyophilisate for the preparation of a solution for intravenous administration is indicated for the following diseases:

- duodenal ulcer;

- stomach ulcer without malignancy;

- gastroesophageal reflux disease;

- other conditions accompanied by hypersecretion (for example, Zollinger-Ellison syndrome);

- Prevention of aspiration of acidic stomach contents (Mendelssohn's syndrome during general anesthesia.

Contraindications:

• Hypersensitivity to the active substance or any of the excipients,

• pregnancy

• breastfeeding period

• children under 18 years of age.

Carefully:

Hepatic and / or renal failure liver cirrhosis with portosystemic encephalopathy (in history) immunodeficiency hypersensitivity to H2-histamine receptor blockers (cross-hypersensitivity is possible).

Pregnancy and lactation:

Pregnancy

Famotidine crosses the placenta. No controlled studies have been conducted in humans.

Famotidine is not recommended for use during pregnancy.

Breastfeeding period

Famotidine passes into breast milk in this regard, breastfeeding during the use of the drug Famotidine lyophilisate for the preparation of a solution for intravenous administration should be discontinued.

Fertility

Animal studies using famotidine orally at doses up to 2000 and 500 mg / kg body weight per day did not show any effect of the drug on fertility.

Method of administration and dosage:

The drug Famotidine lyophilisate for the preparation of a solution for intravenous administration is intended only for intravenous administration. The drug Famotidine lyophilisate for the preparation of a solution for intravenous administration is recommended for use in inpatients who cannot take the drug inside. The drug Famotidine lyophilisate for the preparation of a solution for intravenous administration can be used until oral therapy becomes possible.

In case of duodenal ulcer, gastric ulcer without malignancy of gastroesophageal reflux disease :

The recommended dose is 20 mg intravenously twice a day (every 12 hours).

With Zollinger-Ellison syndrome :

The starting dose is 20 mg intravenously every 6 hours.

Further: the dose of the drug depends on the volume of secretion and the clinical condition

the patient.

With general anesthesia, to prevent aspiration of acidic stomach contents :

Famotidine is used in a dose of 20 mg on the morning of the operation or at least 2 hours before the start of the operation.

A single dose for intravenous administration may not exceed 20 mg. For intravenous injection, the contents of the vial should be dissolved in 5-10 ml of 09% sodium chloride solution (solvent ampoule) and then slowly injected (for at least 2 minutes). The prepared injection solution can be stored for 8 hours at room temperature.

If the drug is administered by infusion, the duration of the infusion should be 15-30 minutes. Solutions should be prepared immediately prior to administration. The following compatible solutions are recommended for dilution:

- glucose solution 5% (valid for 5 hours);

- Ringer's solution (valid for 8 hours);

- Ringer's lactate solution (valid for 8 hours);

- sodium chloride solution 09% is usable within 8 hours.

Only clear, colorless solutions can be used.

Application for renal failure :

Since famotidine is excreted primarily by the kidneys in patients with severe renal impairment, precautions must be taken. If creatinine clearance is less than 30 ml / min and serum creatinine concentration exceeds 3 mg / 100 ml, then the daily dose should be reduced to 20 mg or the intervals between injections should be increased to 36-48 hours.

Use in children and adolescents under 18 years of age :

The safety and efficacy of the drug in children and adolescents under 18 years of age have not been established.

Use in elderly patients (over 65 years old) :

No dose adjustment depending on age is required.

Overdose:

In patients with the syndrome of pathological hypersecretion, doses of up to 800 mg per day were used for a period of more than one year, which was not accompanied by the occurrence of serious adverse events.

Overdose treatment: symptomatic and supportive therapy; monitoring the patient's condition.

Interaction:

Famotidine has no effect on the liver cytochrome P450 system. In connection with an increase in the pH of gastric juice, it can reduce the degree of absorption of ketoconazole with simultaneous use.

With the combined use of famotidine and drugs that depress the bone marrow, the risk of developing neutropenia increases. Famotidine increases the absorption of amoxicillin and clavulanic acid.

Special instructions:

Before intravenous administration of famotidine or if this is not possible before switching to therapy with oral forms, it is necessary to exclude the presence of a malignant neoplasm of the stomach.

In liver failure, Famotidine should be prescribed with caution in a reduced dose.

ѕоскольку в случае использовани¤ блокаторов Ќ2-гистаминовых рецепторов была описана перекрестна¤ гиперчувствительность применение препарата ‘амотидин у пациентов имеющих в анамнезе гиперчувствительность к другим блокаторам Ќ2-гистаминовых рецепторов требует осторожности. ѕодобно всем блокаторам Ќ2-рецепторов при резком прекращении лечени¤ фамотидин может вызывать синдром отмены поэтому лечение прекращают постепенно снижа¤ его дозу.

¬ли¤ние на способность управл¤ть трансп. ср. и мех.:

ѕациентам следует соблюдать осторожность при управлении транспортными средствами и работе с механизмами поскольку во врем¤ лечени¤ может возникать головокружение и наблюдатьс¤ повышенна¤ утомл¤емость.

‘орма выпуска/дозировка:

Ћиофилизат дл¤ приготовлени¤ раствора дл¤ внутривенного введени¤ 20 мг.

”паковка:

Ћиофилизат Ћиофилизат содержащий 20 мг фамотидина во флаконы из трубки стекл¤нной укупоренные пробкой резиновой и обжатые колпачками алюминиевыми или колпачками алюминиевыми комбинированными или колпачками алюминиевыми 'flip-off'.

ѕо 5 флаконов с препаратом помещают в контурную ¤чейковую упаковку из пленки ѕ¬’ без покрыти¤.

–астворитель. ѕо 5 мл 09% раствор натри¤ хлорида в ампулы нейтрального стекла с точкой или кольцом излома.

ѕо 5 ампул с растворителем помещают в контурную ¤чейковую упаковку из пленки ѕ¬’ без покрыти¤.

ѕо 1 контурной ¤чейковой упаковке с препаратом и по 1 контурной ¤чейковой упаковке с растворителем вместе с инструкцией по применению помещают в картонную пачку.

”слови¤ хранени¤:

¬ защищенном от света месте при температуре не более 25 ?—.

’ранить в недоступном дл¤ детей месте.

Shelf life:

2 years.

Do not use the drug after the expiration date indicated on the package.

Vacation conditions

On prescription