Amben (Solution) Instructions for Use

Marketing Authorization Holder

Profit Medica JSC (Russia)

Manufactured By

Pharmazashchita SPC, FSUE FMBA of Russia (Russia)

ATC Code

B02AA03 (Aminomethylbenzoic acid)

Active Substance

Aminomethylbenzoic acid (Ph.Eur. European Pharmacopoeia)

Dosage Form

Amben

Solution for intravenous and intramuscular administration 10 mg/1 ml: 5 ml amp. 10, 20, 50 or 100 pcs.

Dosage Form, Packaging, and Composition

Solution for intravenous and intramuscular administration colorless, transparent.

Excipients: sodium chloride – 9 mg, water for injections – up to 1 ml.

5 ml – ampoules (5) – contour cell packs (2) – cardboard packs.
5 ml – ampoules (5) – contour cell packs (4) – cardboard packs.
5 ml – ampoules (5) – contour cell packs (10) – cardboard packs.
5 ml – ampoules (5) – contour cell packs (20) – cardboard packs.

Clinical-Pharmacological Group

Hemostatic agent. Fibrinolysis inhibitor – inhibitor of plasminogen to plasmin conversion

Pharmacotherapeutic Group

Hemostatic agent

Pharmacological Action

Antifibrinolytic agent, a derivative of aminocaproic acid.

It has a hemostatic effect by competitively inhibiting enzymes – kinases (plasmic, tissue, streptokinase) that activate the conversion of profibrinolysin (plasminogen) to fibrinolysin (plasmin).

Pharmacokinetics

After oral administration, Aminomethylbenzoic acid is detected in the blood after 15 minutes.

C_max is reached after 3 hours.

After intramuscular injection, Aminomethylbenzoic acid undergoes rapid resorption, C_max in the blood is reached after 30-60 minutes.

After intravenous injection of the drug at a dose of 1.5 mg/kg, the concentration of aminomethylbenzoic acid in the blood decreases rapidly and after 3 hours reaches a level where the active substance is practically undetectable.

Aminomethylbenzoic acid is excreted by the kidneys through glomerular filtration and tubular secretion, with 50-60% excreted unchanged.

Indications

Local bleeding due to increased fibrinolysis in surgical, urological, and gynecological practice; generalized fibrinolytic bleeding (including during fibrinolytic therapy, during operations on the organs of the thoracic and abdominal cavities; in prostate cancer; in leukemia; in obstetric practice with delayed postpartum uterine involution, after medical abortion, after manual separation of the placenta, with intrauterine fetal death, amniotic fluid embolism).

ICD codes

Dosage Regimen

Administer the dosage individually, tailored to the specific clinical situation and bleeding severity.

For intravenous administration, inject a single dose of 50-100 mg (1-2 ampoules) slowly over at least 5 minutes.

For intramuscular administration, inject a single dose of 50-100 mg (1-2 ampoules) deeply into the muscle.

Repeat the administration 3-4 times daily for the duration of the hemorrhagic threat.

In cases of severe bleeding, administer an initial intravenous dose of 100 mg, followed by continuous intravenous infusion.

For continuous infusion, dilute the required daily dose in 0.9% sodium chloride solution and administer at a rate of 50 mg (1 ampoule) per hour.

The maximum single dose for intravenous administration is 200 mg (4 ampoules).

The maximum daily dose for any route of administration is 600 mg (12 ampoules).

Adjust the dosage and duration of therapy based on clinical response and coagulogram parameters.

In obstetric practice, administer 100 mg (2 ampoules) intravenously or intramuscularly, repeating as necessary.

Discontinue use once hemostasis is adequately achieved.

Adverse Reactions

From the digestive system: nausea, vomiting, diarrhea.

From the cardiovascular system: fluctuations in blood pressure, tachycardia.

From the central nervous system: dizziness.

Contraindications

Severe renal impairment, first trimester of pregnancy, hemorrhage into the vitreous body, hypercoagulable phase of consumption coagulopathy, hypersensitivity to aminomethylbenzoic acid.

Use in Pregnancy and Lactation

Contraindicated in the first trimester of pregnancy.

It is possible to use in obstetric practice according to indications.

Experimental studies have shown that Aminomethylbenzoic acid is a compound with low toxicity. No teratogenic effects or effects on the reproductive system were identified.

Use in late pregnancy and during breastfeeding is possible in cases where the expected benefit of therapy for the mother outweighs the potential risk to the fetus or breastfed infant.

Use in Hepatic Impairment

Used for liver diseases according to indications.

Use in Renal Impairment

Contraindication: severe renal impairment.

When treating hematuria with aminomethylbenzoic acid, the formation of blood clots in the urinary tract is possible, which can lead to renal colic. Therefore, it is necessary to ensure sufficient fluid intake and control diuresis.

Geriatric Use

Use with caution due to the risk of adverse reactions and taking into account contraindications.

Special Precautions

Use with caution in patients with a predisposition to thrombosis. Treatment is carried out under the control of a coagulogram. When treating hematuria with aminomethylbenzoic acid, the formation of blood clots in the urinary tract is possible, which can lead to renal colic. Therefore, it is necessary to ensure sufficient fluid intake and control diuresis.

Drug Interactions

Simultaneous use of aminomethylbenzoic acid in high doses and other hemostatic agents (for example, etamsylate) can lead to the formation of blood clots on the one hand – due to increased fibrin formation under the action of hemostatics, and on the other hand – due to the slow dissolution of clots due to the antiplasmin action of aminomethylbenzoic acid.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.