Otsutran-40

Uses

This is used for Aid in Hysteroscopy, Thromboembolic disorders, Prophylaxis of pulmonary embolism or venous thrombosis in moderate- to high-risk patients undergoing surgery, Prophylaxis of postoperative thromboembolic disorders, Hypovolaemic shock.

Otsutran-40 is also used to associated treatment for these conditions: Blood Circulation Disorder, Capillary disorder, Dry Eyes, Ocular Irritation, Pulmonary Embolism, Pulmonary Embolism caused by procedures associated with a high incidence of thromboembolic complications, Shock, Thrombosis, Venous, Venous Thrombosis caused by procedures associated with a high incidence of thromboembolic complications, Thrombotic events, Plasma Volume Replacement, Priming fluid in pump oxygenators therapyAllergic Rhinitis (AR), Corneal Edema, Dehydration, Dehydration Hypertonic, Fluid Loss, Hemodilution, Hypertension Intracranial, Hypokalemia, Hyponatremia, Hypotonic Dehydration, Hypovolaemia, Increased Intra Ocular Pressure (IOP), Inflammation of the Nasal Mucosa, Isotonic Dehydration, Metabolic Acidosis, Nasal Congestion, Nasal irritation, Oliguria caused by Acute Renal Failure (ARF), Potassium deficiency, Sinusitis, Skin Irritation, Sodium Depletion, Dryness of the nose, Hypochloremic state, Mild Metabolic acidosis, Mild, moderate Metabolic Acidosis, Electrolyte replacement, Fluid replacement therapy, Heart-Lung-Machine, Oral rehydration therapy, Parenteral Nutrition, Parenteral rehydration therapy, Peritoneal dialysis therapy, Plasma Volume Replacement, Regional Citrate Anticoagulation (RCA), Renal Replacement Therapies, Urine alkalinization therapy, Wound irrigation therapy, Ear wax removal, Fluid and electrolyte maintenance therapy, Increased renal excretion of toxic substances, Maintenance source of fluid and electrolytes, Parenteral drug administration, Reducing brain mass

How Otsutran-40 works

In preclinical studies, the mechanism of action is thought to be related to the blockage of the uptake of tissue plasminogen activator by mannose-binding receptors. This process has a direct effect by enhancing endogenous fibrinolysis.

Sodium and chloride — major electrolytes of the fluid compartment outside of cells (i.e., extracellular) — work together to control extracellular volume and blood pressure. Disturbances in sodium concentrations in the extracellular fluid are associated with disorders of water balance.

Dosage

Otsutran-40 dosage

Intrauterine-Aid in hysteroscopy:

• Adult: As dextran 70: 50-100 mL of a 32% solution instilled into the uterus as a rinsing and dilatation fluid.

Intravenous-

Thromboembolic disorders:

• Adult: As dextran 40: Initially, 500 ml of a 10% solution in sodium chloride 0.9% or glucose 5% infused over 4-6 hr, followed by 500 ml infused over 4-6 hr on the next and subsequent alternate days for not more than 10 days.
• Child: As dextran 40: Up to 5 ml/kg in infants and 10 ml/kg in children.

Intravenous-

Prophylaxis of pulmonary embolism or venous thrombosis in moderate- to high-risk patients undergoing surgery:

• Adult: As dextran 70: Initially, 500-1000 mL of a 6% solution in sodium chloride 0.9% or glucose 5% infused over 4-6 hr during or immediately after surgery, followed by 500 mL on the next day and on subsequent alternate days for up to 2 wk after surgery in high-risk patients.

Intravenous-

Prophylaxis of postoperative thromboembolic disorders:

• Adult: As dextran 40: 500 ml of a 10% solution in sodium chloride 0.9% or glucose 5% infused over 4-6 hr during or at the end of the surgery. Dose may be repeated the following day and treatment may be continued on alternate days for up to 10 days in high-risk patient.
• Child: As dextran 40: Up to 10 ml/kg in children.

Intravenous-

Hypovolaemic shock:

• Adult: As dextran 40: Initially, 10 ml/kg given by rapid infusion as a 10% solution in sodium chloride 0.9% or glucose 5%. Doses may be given daily for up to 5 days. As dextran 70: Initially, 500-1000 mL of a 6% solution in sodium chloride 0.9% or glucose 5% infused at a rate of 20-40 mL/min. Maintenance: 10 ml/kg/day for3 days (Dextran 70).

Side Effects

GI disturbances; headache, dizziness; allergic reactions; raised liver enzyme values; alopecia; bone marrow suppression.

Toxicity

Some reports have shown adverse effects when used in therapeutical doses and some teratogenic effects have been demonstrated when used in large doses. The current LD50 reported in rats is 10700 mg/kg.

The rare inadvertent intravascular administration or rapid intravascular absorption of hypertonic sodium chloride can cause a shift of tissue fluids into the vascular bed, resulting in hypervolemia, electrolyte disturbances, circulatory failure, pulmonary embolism, or augmented hypertension.

Precaution

Lactation.

Interaction

Dextran: Enzyme inducers e.g. phenytoin or carbamazepine and enzyme inhibitors e.g. cimetidine.

Sodium Chloride: May affect serum concentrations of lithium.

Volume of Distribution

The reported volume of distribution of dextran suggested a distribution throughout the blood volume. This volume of distribution is reported to be of around 120 ml. The organ that presented a higher accumulation of dextran was the liver.

The volume of distribution is 0.64 L/kg.

Elimination Route

Dextran presents a very low oral bioavailability that is reduced as the chain gets longer. Thus, the bioavailability of dextran is inversely proportional to the length of the carbohydrate chain.

Absorption of sodium in the small intestine plays an important role in the absorption of chloride, amino acids, glucose, and water. Chloride, in the form of hydrochloric acid (HCl), is also an important component of gastric juice, which aids the digestion and absorption of many nutrients.

Half Life

The elimination half-life will depend on the length of the carbohydrate chain. The higher the molecular weight of the dextran the longer it will be the elimination half-life. The half-life will go from 1.9 hours from dextran 1 to 42 hours in the case of dextran 60.

17 minutes

Elimination Route

The elimination of dextran will depend on the length of the carbohydrate chain, the administration route, and the molecular weight. For dextran 1, it is reported to be mainly secreted unchanged in the urine in a ratio of 80% of the administered dose when administered parentally. It is registered that the weight threshold for unrestricted glomerular filtration is about 15 kDa and if the dextran overpasses 50 kDa it will not be renally eliminated in any significant amount.

Substantially excreted by the kidneys.

Pregnancy & Breastfeeding use

Category C: Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.

Contraindication

Hypersensitivity. Severe renal disease with oliguria or anuria. Marked cardiac decompensation. Pregnancy.

Storage Condition

Store at 25°C.

Innovators Monograph

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