Sansamik - Instructions For Use, Tablets, Ampoules, Reviews

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Sanksamik

Sansamik: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacological properties
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Application during pregnancy and lactation
10. 10. Use in childhood
11. 11. In case of impaired renal function
12. 12. For violations of liver function
13. 13. Use in the elderly
14. 14. Drug interactions
15. 15. Analogs
16. 16. Terms and conditions of storage
17. 17. Terms of dispensing from pharmacies
18. 18. Reviews
19. 19. Price in pharmacies

Latin name: Sanxamik

ATX code: B02AA02

Active ingredient: tranexamic acid (Tranexamic acid)

Manufacturer: Sanjivani Paranteral, Limited (India)

Description and photo update: 2019-18-12

Sansamik is a hemostatic drug.

Release form and composition

Dosage forms of Sanksamik:

• solution for intravenous (iv) administration: colorless transparent liquid (5 ml each in ampoules made of transparent colorless glass with a break line in the upper part, 5 ampoules each in blisters, 1 package in a cardboard box);
• film-coated tablets: from white to almost white, round, biconvex, core - from almost white to white (10 pcs. in blisters, in a cardboard box 3 blisters; for hospitals - 100, 500 or 1000 pcs. in plastic bags, 1 bag each in plastic cans, sealed with aluminum foil with a polyethylene coating, with a screw cap, in a cardboard box 1, 5, 10, 20 or 40 cans).

Each pack also contains instructions for the use of Sanksamik.

1 ml of solution contains:

• active substance: tranexamic acid - 50 mg or 100 mg;
• auxiliary component: water for injection.

1 tablet contains:

• active substance: tranexamic acid - 250 mg or 500 mg;
• auxiliary components: microcrystalline cellulose, croscarmellose sodium, povidone K-30, magnesium stearate, colloidal silicon oxide, purified talc;
• the composition of the film shell: hypromellose, diethyl phthalate, propylene glycol, titanium dioxide.

Pharmacological properties

Pharmacodynamics

Sansamik is a hemostatic drug with antiallergic and anti-inflammatory effects. The active substance of the drug is tranexamic acid, a synthetic antifibrinolytic, which is a competitive, and at high concentrations - non-competitive, inhibitor of plasminogen activation and its conversion to plasmin.

With bleeding caused by an increase in fibrinolysis (platelet pathology, menorrhagia), it has a local and systemic hemostatic effect.

The mechanism of the anti-allergic and anti-inflammatory effect of Sanksamik is due to the ability of tranexamic acid to suppress the formation of active peptides (including kinins) involved in allergic and inflammatory reactions.

Tranexamic acid at a concentration of 1 mg / ml of blood prolongs thrombin time, but does not aggregate platelets in vitro. In a healthy person, its plasma content up to 10 mg / ml does not affect the platelet count, clotting time and other clotting factors in whole or citrated blood.

Pharmacokinetics

After taking Sanksamik orally in the range of a daily dose from 500 mg to 2000 mg, 30-50% of tranexamic acid is absorbed. While taking the drug at a dose of 500, 1000 and 2000 mg, the maximum concentration (C _max) in the blood plasma is achieved after 3 hours and is 0.005; 0.008 and 0.015 mg / ml, respectively.

After oral and parenteral administration, the substance is distributed relatively evenly in all tissues, with the exception of cerebrospinal fluid, the content of which is 1/10 of the plasma level. Overcomes the blood-brain barrier (BBB). Penetrates through the placental barrier, after intravenous administration of a pregnant woman at a dose of 10 mg / kg, in umbilical cord blood it can be approximately 0.03 mg / ml of fetal serum. It is excreted in breast milk (about 1% of the concentration in the mother's blood plasma). Tranexamic acid decreases fibrinolytic activity in semen, but does not affect sperm migration. It diffuses quickly into the joint fluid and through the synovial membranes, reaching a level in the joint fluid similar to that in the blood serum. Biological half-life (T _1/2) from the articular fluid - about 3 hours. The antifibrinolytic concentration of tranexamic acid in the plasma is maintained for 7-8 hours, in other tissues - 17 hours.

Plasma protein binding (mainly profibrinolysin) is less than 3%.

The initial volume of distribution is 9–12 liters.

Less than 5% of tranexamic acid is metabolized. Two metabolites have been identified: an N-acetylated derivative and a deaminated derivative.

AUC (area under the concentration-time curve) has a three-phase form, T _1/2 in the terminal phase after intravenous administration is 2 hours, after oral administration - 3 hours. The total renal clearance is similar to plasma clearance and is 7 l / h …

More than 95% of the received dose is excreted unchanged through the kidneys during the first 12 hours. The main route of excretion for parenteral administration is glomerular filtration, for oral administration - glomerular filtration. After intravenous administration at a dose of 10 mg / kg for 24 hours, approximately 90% of tranexamic acid is excreted. In patients with impaired renal function, its cumulation is possible.

Indications for use

Solution for intravenous administration

The use of Sanksamik solution in ampoules is indicated for the prevention and treatment of the following bleeding caused by generalized or local fibrinolysis in adults and children aged 1 year and older:

• gastrointestinal bleeding;
• menorrhagia and metrorrhagia;
• obstetric and gynecological bleeding;
• bleeding during thoracic, abdominal or other major surgical interventions (including cardiac surgery);
• bleeding after surgery on the urinary tract and prostate gland;
• bleeding during gynecological surgery;
• bleeding during surgery in the nasal cavity, mouth or pharynx (including tooth extraction, adenoidectomy, tonsillectomy);
• bleeding resulting from the use of fibrinolytic drugs.

Film-coated tablets

Taking Sanksamik tablets is indicated for increased generalized or local fibrinolysis for the prevention and treatment of the following bleeding in patients over the age of 18:

• surgical interventions on the organs of the urinary system, including prostatectomy;
• hematuria;
• menorrhagia;
• nosebleeds;
• conization of the cervix;
• uterine bleeding, including those caused by coagulopathy, including von Willebrand disease;
• obstetric complications: postpartum hemorrhage, placental abruption, manual separation of the placenta, bleeding;
• traumatic hyphema;
• extraction of teeth in patients with coagulopathy;
• gastrointestinal bleeding, including ulcerative colitis;
• malignant neoplasms of the prostate and pancreas;
• extensive surgical operations, including interventions on the chest organs;
• concomitant thrombolytic therapy with streptokinase for leukemia and liver disease;
• hereditary angioedema;
• blood transfusion in patients after heart surgery, total arthroplasty of the knee or hip joints - in order to reduce peri- and postoperative blood loss.

Contraindications

Absolute contraindications common to both dosage forms of Sanksamik:

• subarachnoid hemorrhage;
• a history of convulsive syndrome;
• severe chronic renal failure [glomerular filtration rate (GFR) less than 30 mg / ml / 1.73 m ²];
• pulmonary embolism, deep vein thrombosis of the legs, intracranial thrombosis and other types of venous and arterial thrombosis (including history) - if simultaneous anticoagulant therapy is impossible;
• acquired disorders of color vision;
• hypersensitivity to drug components.

Additional contraindications for certain dosage forms of Sanksamik:

• solution for intravenous administration: fibrinolysis due to coagulopathy of consumption [hypocoagulative stage of disseminated intravascular coagulation syndrome (DIC)]; treatment of menorrhagias in patients under 16 years of age; age under 1 year;
• tablets: fibrinolysis due to coagulopathy of consumption, except for the predominant activation of the fibrinolytic system in cases of severe acute bleeding; age up to 18 years.

The solution and tablets should be used with caution in the presence of hematuria caused by diseases of the renal parenchyma; bleeding from the upper urinary tract; a history of thromboembolic complications or a complicated family history of thromboembolism; while using combined oral contraceptives, concomitant therapy with anticoagulants or anti-inhibitory coagulant complex.

In addition, when prescribing each of the forms of Sanksamik, it is recommended to be careful in the following cases:

• solution: simultaneous use of drugs of the prothrombin complex (blood coagulation factors II, VII, IX and X in combination);
• tablets: concomitant therapy with drugs of clotting factor IX-complex; renal impairment, accumulation of blood in the bladder and the calyceal system of the kidney, pleural cavity or articular cavity; heavy bleeding from the upper urinary system; irregular menstrual bleeding; verified diagnosis of thrombophilia; an indication of a history of color vision impairment; DIC syndrome; heparin therapy.

With caution, only in cases of special need, it is recommended to resort to the appointment of Sanksamik during pregnancy and lactation.

Sansamik, instructions for use: method and dosage

Solution for intravenous administration

Sanksamik solution in ampoules is used by drip or slow jet (1 ml / min) intravenous injection.

Do not allow rapid administration of the drug.

Recommended dosage regimen of Sanksamik for adults:

• gastrointestinal bleeding, menorrhagia and metrorrhagia: from the moment the bleeding appears until it stops - 500 mg (1 ampoule at a dosage of 100 mg / ml or 2 ampoules at a dosage of 50 mg / ml) 2-3 times a day;
• treatment of bleeding after surgical operations on the urinary tract and the prostate gland: from the moment of bleeding development to its stop - 1000 mg 3 times a day;
• prevention and treatment of bleeding during surgical interventions in the nasal cavity, mouth and pharynx: at the rate of 10-15 mg / kg of the patient's body weight 3-4 times a day at regular intervals until the bleeding stops;
• prevention and treatment of bleeding during thoracic, abdominal and other extensive interventions: 15 mg / kg of body weight 3-4 times a day at regular intervals until the bleeding stops;
• prevention and treatment of bleeding during cardiac surgery: loading dose (after the onset of anesthesia immediately before surgery) - 15 mg / kg body weight. Then, during the entire operation, intravenous infusion is carried out (rate - 4.5 mg / kg per hour), it is recommended to introduce Sanksamik into the heart-lung machine at a dose of 0.6 mg / kg of body weight;
• treatment of obstetric-gynecological bleeding and bleeding during gynecological surgical interventions: from the moment of bleeding to its stopping - 15 mg / kg of body weight 3-4 times a day at regular intervals;
• treatment of bleeding caused by the use of fibrinolytic drugs: from the moment of the development of bleeding until it stops - 10 mg / kg of body weight 3-4 times a day at regular intervals.

If it is necessary to use hemostatic therapy for more than 2 days, the patient should be transferred to the use of oral forms of tranexamic acid.

The recommended daily dosage of Sanksamik for children over 1 year old in the treatment of bleeding caused by local and generalized fibrinolysis: 20 mg / kg of the child's body weight.

In patients with impaired liver function or in old age (provided there is no renal failure), dose adjustment is not required.

The recommended dosage regimen of Sanksamik in case of mild and moderate impairment of renal excretory function:

• serum creatinine concentration index - 120-249 μmol / l (1.36-2.82 mg / dl) and GFR - 60-89 ml / min / 1.73 m ²: based on 15 mg / kg body weight 2 times a day;
• serum creatinine concentration index - 250-500 μmol / l (2.83-5.66 mg / dl) and GFR - 30-59 ml / min / 1.73 m ²: 15 mg / kg body weight 1 time in a day.

In severe chronic renal failure (GFR less than 30 mg / ml / 1.73 m ²), the use of Sanksamik is contraindicated.

Film-coated tablets

Sansamik tablets are taken orally, swallowing whole (without violating the integrity of the film shell) and drinking water.

Recommended dosage regimen:

• local fibrinolysis: usually 1000-1500 mg 2-3 times a day or the daily dose is determined at the rate of 20-25 mg / kg of body weight;
• prostatectomy: after three days of parenteral administration of the drug, the patient is transferred to taking tablets at a dose of 1000–1500 mg 3-4 times a day during the period until the absence of hematuria is confirmed;
• hematuria: 1000-1500 mg 2-3 times a day until the complete absence of hematuria, confirmed by the results of a macroscopic examination;
• menorrhagia (with profuse bleeding): 1000-1500 mg 3-4 times a day, course duration 3-4 days;
• bleeding against the background of coagulopathies (including von Willebrand disease): 1000-1500 mg 3-4 times a day for 3-10 days;
• nosebleeds: 1000 mg 3 times a day, the course of treatment is 4 to 10 days;
• bleeding after conization of the cervix: 1500 mg 3 times a day, the duration of therapy is 12-14 days;
• bleeding during pregnancy: 250-500 mg 3-4 times a day until the bleeding stops completely, on average - 7 days;
• traumatic hyphema: 1000-1500 mg 3 times a day;
• tooth extraction in patients with coagulopathy: 25 mg / kg of body weight 3-4 times a day. The period of application of Sanksamik is from 6 to 8 days;
• hereditary angioedema: continuous or intermittent therapy at a dose of 1000-1500 mg 2-3 times a day. The treatment regimen depends on the presence of prodromal signs of angioedema in the patient.

In case of bleeding caused by generalized fibrinolysis, treatment begins with intravenous administration of tranexamic acid, and after a few days the patient is transferred to Sanksamik in the form of tablets at a dose of 1000-1500 mg 2-3 times a day.

In case of impaired renal function, the following dosing regimen is recommended, depending on the serum creatinine level:

• 120–249 μmol / l: at the rate of 15 mg / kg of body weight 2 times a day;
• 250-500 μmol / l: 15 mg / kg of body weight once a day;
• more than 500 μmol / l: 7.5 mg / kg of body weight once a day.

Side effects

Possible side reactions to the use of tranexamic acid:

• from the nervous system: rarely - convulsions, dizziness;
• from the digestive system: often - diarrhea, nausea, vomiting;
• on the part of the organ of vision: rarely - a violation of color perception and other visual disturbances, thrombosis of the retinal vessels;
• from the side of the vessels: rarely - thromboembolic complications; very rarely - venous and arterial thrombosis of various localization;
• on the part of the immune system: very rarely - the development of hypersensitivity reactions, up to anaphylactic shock;
• dermatological reactions: rarely - allergic skin reactions, including allergic dermatitis.

In addition, against the background of the use of Sanksamik in the form of a solution from the side of the vessels, the following undesirable phenomena can be observed: rarely - a pronounced decrease in blood pressure (BP), this usually happens after a rapid intravenous injection; the frequency has not been established - deep vein thrombosis of the legs, thrombosis of the cerebral arteries, thromboembolism of the pulmonary artery, thrombosis of the carotid arteries, the development of cortical necrosis and acute renal failure due to thrombosis of the renal artery, occlusion of aortocoronary shunt, acute myocardial infarction, arteries and retinal vein thrombosis.

The use of pills can very rarely cause a decrease in blood pressure (including loss of consciousness) and be accompanied by a feeling of malaise.

Overdose

Symptoms of tranexamic acid overdose are nausea, vomiting, diarrhea, headache, dizziness, orthostatic hypotension.

There is no specific antidote, therefore symptomatic treatment in a hospital setting is indicated. Not later than the first two hours after an overdose of the oral form of Sanksamik, it is advisable to wash the stomach, induce vomiting, and take activated charcoal. It is necessary to carry out forced diuresis with simultaneous control of the amount of urine excreted. It should be borne in mind that patients with a predisposition to thromboembolic complications are at risk of thrombosis. Careful monitoring of the state of the patient's vital organs and systems is required.

In very severe cases, the use of anticoagulants is considered justified.

special instructions

If it is necessary to prescribe Sansamik, an ophthalmologist's consultation is required regarding the patient's condition of visual acuity, fundus, color perception. Similar checks are carried out during the period of use of the drug, and in the event of any violations on the part of the organ of vision, treatment is immediately stopped.

It should be borne in mind that tranexamic acid may aggravate renal conditions in patients with hematuria due to renal parenchymal disease due to the high risk of intravascular fibrin deposition. In addition, with massive bleeding from the upper urinary tract of any etiology against the background of antifibrinolytic therapy, blood clots may form in the renal pelvis and / or ureter. This significantly increases the risk of secondary mechanical obstruction of the urinary tract and the development of anuria.

Prescribe Sanksamik to patients with a history of thromboembolic events or cases of thromboembolism in close relatives should be prescribed only if absolutely necessary. Treatment of such patients should take place under close medical supervision.

With irregular menstrual bleeding, it is possible to start using Sanksamik only after establishing the cause. In the case of an inadequate decrease in the volume of menstrual bleeding during treatment with tranexamic acid, it is recommended to consider switching to alternative methods of therapy.

In children under 1 year of age, clinical experience with the use of tranexamic acid solution is limited, therefore, in this category of patients, the administration of Sanksamic is allowed, but only in special cases when the expected therapeutic effect outweighs the potential risk of seizures associated with immaturity of renal function and the blood-brain barrier.

The simultaneous use of anticoagulants should be carried out under the strict supervision of a physician in the treatment of blood coagulation disorders.

The use of tranexamic acid in patients with disseminated intravascular coagulation should be accompanied by the strict supervision of a specialist with experience in the treatment of this disease.

Patients with coagulopathy during tooth extraction may require the use of a coagulation factor concentrate. The decision on its appointment is made after consultation with the hemostasiologist.

Influence on the ability to drive vehicles and complex mechanisms

During the period of use of Sansamic, it is necessary to take into account the ability of tranexamic acid to cause dizziness, visual impairment and convulsions. In this connection, it is important to be careful when performing potentially hazardous types of work that require speed of psychomotor reactions and increased concentration of attention, including when driving vehicles and complex mechanisms.

Application during pregnancy and lactation

It is recommended to use Sanksamik with caution during pregnancy and breastfeeding due to the lack of reliable information on the effects of tranexamic acid on the fetus and child.

The effect of tranexamic acid on fertility has not been established.

Pediatric use

It is contraindicated to use Sanksamik in the following age groups:

• solution for intravenous administration: infants under 1 year old;
• film-coated tablets: children and adolescents under 18 years of age.

Additionally: do not use Sanksamik solution for the treatment of menorrhagia in girls under the age of 16.

With impaired renal function

The use of Sanksamik is contraindicated in severe chronic renal failure (GFR less than 30 mg / ml / 1.73 m ²).

Care should be taken to prescribe the solution and tablets to patients with hematuria caused by diseases of the renal parenchyma, bleeding from the upper urinary tract. In addition, caution is required when taking pills for renal disorders, accumulation of blood in the bladder and the renal calyx-pelvic system, heavy bleeding from the upper urinary system.

For violations of liver function

Patients with impaired liver function do not require dose adjustment of Sanksamik.

Use in the elderly

Elderly patients with normal renal function do not require dose adjustment of tranexamic acid.

Drug interactions

With simultaneous use with tranexamic acid:

• preparations of the prothrombin complex (a combination of coagulation factors II, VII, IX and X), anti-inhibitory coagulant complex: the combination with these agents increases the risk of thrombosis;
• thrombolytics: tranexamic acid prevents the implementation of the pharmacological effect of fibrinolytic drugs;
• combined oral contraceptives: the existing risk of venous thromboembolic complications and arterial thrombosis (including ischemic stroke, myocardial infarction) due to the presence of estrogens in combined contraceptives increases;
• hydrochlorothiazide, desmopressin, ampicillin + sulbactam, ranitidine, nitroglycerin: when combined with these agents, the risk of developing myocardial infarction or other thrombotic complications increases;
• hemostatic drugs: the combination with other hemostatic agents increases the risk of thrombus formation.

Tranexamic acid solution is pharmaceutically compatible with 0.9% sodium chloride solution, Ringer's solution, 5% dextrose solution, amino acid solutions, dextran, unfractionated heparin. Do not mix the solution with urokinase, norepinephrine, dipyridamole, diazepam, penicillins, tetracyclines and blood products.

Analogs

The analogs of Sanksamik are Bitranex, GEMTRANIX, Stagemin, Traxara, Trameston, Tranexam, Tranexamic acid, Tranexamic acid-Akrihin, Troxaminat, Cyclohemal, etc.

Terms and conditions of storage

Keep out of the reach of children.

Store at temperatures up to 25 ° C, do not freeze the solution.

Shelf life: solution - 2 years, tablets - 3 years.

Terms of dispensing from pharmacies

Sansamik solution is available with a prescription, tablets - without a prescription.

Reviews about Sanksamik

There are currently no reviews of specialists or patients about Sansamik.

Price for Sanksamik in pharmacies

Price for Sanksamik per package:

• film-coated tablets (30 pcs.): in a dosage of 250 mg - from 373 rubles, in a dosage of 500 mg - from 654 rubles;
• solution for intravenous administration (5 ampoules): at a dosage of 50 mg / ml - from 533 rubles, at a dosage of 100 mg / ml - from 640 rubles.

Anna Kozlova Medical journalist About the author

Education: Rostov State Medical University, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!