Pituitrin recipe in Latin. Pharmacological group - Choleretic agents and bile preparations. Pituitrin - side effects

Name:

Pituitrinum

Pharmachologic effect:

It has oxytocic (stimulating contractions of the uterine muscles), vasopressor (vasoconstrictor) and antidiuretic (reducing urine secretion) effects.

Indications for use:

To stimulate and enhance uterine contractions during weak labor, post-term pregnancy, hypotonic bleeding (associated with decreased uterine tone) and to normalize uterine involution (uterine contractions in the postpartum period).

Method of application:

Subcutaneously and intramuscularly, 0.2-0.25 ml every 15-30 minutes 4-6 times. To prevent and stop hypotonic uterine bleeding in the early postpartum period, if necessary, administer 1 ml intravenously in 500 ml of a 5% glucose solution or very slowly 0.5-1 ml in 40 ml of a 40% glucose solution.

Higher doses: single - 2 ml, daily - 4 ml.

Adverse events:

Large doses can cause spasms (sharp narrowing of the lumen) of cerebral vessels, collapse (sharp drop in blood pressure), hemodynamic disturbances, tetanic (convulsive) contractions of the uterus during childbirth (in case of overdose).

Contraindications:

Severe atherosclerosis, myocarditis (inflammation of the heart muscle), hypertension (persistent rise in blood pressure), thrombophlebitis (inflammation of the vein wall with blockage), sepsis (blood poisoning), nephropathy of pregnant women (toxicosis of the second half of pregnancy), the presence of scars and the threat of uterine rupture , incorrect position of the fetus.

Release form of the drug:

In ampoules of 1 ml (5 units) in a package of 6 pieces.

Storage conditions:

Drug from list B. In a cool, dark place.

Synonyms:

Glanduitrin, Hypophen, Hypophysin, Python, Pituglandol, Pituigan.

Additionally:

Hormonal preparation of the pituitary gland.

Drugs with similar effects:

Desaminooxytocinum Hyphotocinum Oxytocinum

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1 ampoule contains 5 units oxytocin And vasopressin .

Release form

Solution in ampoules of 1 ml (5 units).

pharmachologic effect

Stimulation of labor.

Pharmacodynamics and pharmacokinetics

Pharmacodynamics

Pituitrin is a hormonal drug obtained from the pituitary gland of livestock. It contains hormones - oxytocin And vasopressin . Biological activity is determined by content oxytocin . Stimulates labor by causing uterine contractions. Has a vasoconstrictor effect and increases HELL due to presence vasopressin . The antidiuretic effect is manifested by an increase in water reabsorption in the kidneys.

Pharmacokinetics

Data not provided.

Indications for use

metrorrhagia ;
weakness of labor;
postpartum hemorrhage;
urinary incontinence;
diabetes insipidus .

Contraindications

increased sensitivity;
hypertonic disease ;
myocarditis ;
expressed atherosclerosis ;
sepsis ;
nephropathy of pregnancy;
scars on the uterus and the threat of its rupture.

Pituitrin should be used with caution when thrombophlebitis .

Side effects

Pituitrin may cause:

hypoxia fetus;
hypertonicity of the uterus;
promotion HELL ;
bronchospasm .

Pituitrin, instructions for use (Method and dosage)

Pituitrin in the form of a solution is administered subcutaneously or intramuscularly. The highest single dose is 10 units.

For uterine bleeding and for contraction of the uterus after childbirth - 0.25 ml every 30 minutes, bringing to a total dose of 1 ml.

For quick delivery, 0.5-1.0 ml is used once in the second stage of labor.

At diabetes insipidus - 1 ml intramuscularly 1-2 times a day.

Overdose

There are no known cases of overdose.

Interaction

No data provided.

Terms of sale

Pituitrin is available by prescription.

Storage conditions

Temperature 1-8°C.

Best before date

Analogs

Oxytocin , Hyfotocin .

Reviews

Strengthen the contractility of the uterus - a synthetic drug oxytocin and natural organopreparations Hyfotocin and Pituitrin, which contains oxytocin And vasopressin , therefore, in addition to the effects inherent in oxytocin, it also increases blood pressure. In gynecological practice, it was used for the same indications as oxytocin: to stimulate labor, for uterine atony, and bleeding. The non-pregnant uterus is more sensitive to vasopressin , and during pregnancy the sensitivity to oxytocin .

The drug Pituitrin is maximally exempt from vasopressin , it is administered intravenously. Hyfotocin has less content vasopressin . Currently, these drugs are not found in pharmacies and are not used. There is an explanation for this. Synthetic oxytocin has the advantage that it has a more selective effect on the uterus, since it does not contain impurities of other hormones and does not significantly affect HELL . In addition, it is free from proteins and can be used intravenously without fear anaphylactic shock and pyrogenic action, therefore for many years it has been widely used in gynecological practice.

Choleretic drugs are drugs that enhance bile formation or promote the release of bile into the duodenum.

Bile ( bilis- lat., fel- English) - a secret produced by hepatocytes. Bile production occurs continuously in the body. Bile produced in the liver is secreted into the extrahepatic bile ducts, which collect it into the common bile duct. Excess bile accumulates in the gallbladder, where it is concentrated 4-10 times as a result of the absorption of water by the mucous membrane of the gallbladder. During the digestion process, bile from the gallbladder is released into the duodenum, where it is included in the processes of digestion and absorption of lipids. The flow of bile into the intestines is regulated by neuro-reflex mechanisms. Of the humoral factors in the process of bile secretion, the most important is cholecystokinin (pancreozymin), which is produced by the mucous membrane of the duodenum when gastric contents enter it and stimulates the contraction and emptying of the gallbladder. As it moves through the intestines, the main part of the bile is absorbed through its walls along with nutrients, the rest (about a third) is removed with feces.

The main components of bile are bile acids (BAs) - 67%, about 50% are primary FAs: cholic, chenodeoxycholic (1:1), the remaining 50% are secondary and tertiary FAs: deoxycholic, lithocholic, ursodeoxycholic, sulfolitocholic. The composition of bile also includes phospholipids (22%), proteins (immunoglobulins - 4.5%), cholesterol (4%), bilirubin (0.3%).

According to their chemical structure, FAs are derivatives of cholanic acid and represent the main end product of cholesterol metabolism. Most of the FAs are conjugated to glycine and taurine, which makes them stable at low pH values. Bile acids facilitate the emulsification and absorption of fats, inhibit cholesterol synthesis via a feedback mechanism, and the absorption of fat-soluble vitamins (A, D, E, K) depends on their presence. In addition, bile acids increase the activity of pancreatic enzymes.

Disturbances in the formation or outflow of bile into the duodenum can be of different nature: liver disease, biliary dyskinesia, increased lithogenicity of bile, etc. When choosing a rational choleretic agent, it is necessary to take into account the pharmacodynamics of choleretic drugs.

Depending on the leading mechanism of action, choleretic agents are divided into two subgroups: agents that enhance the formation of bile and bile acids ( Choleretica, Cholesecretica), and means that promote its release from the gallbladder into the duodenum ( Cholagoga, or Cholekinetica). This division is quite arbitrary, because Most choleretic drugs simultaneously enhance the secretion of bile and facilitate its entry into the intestines.

The mechanism of action of choleretics is due to reflexes from the intestinal mucosa (especially when using drugs containing bile, bile acids, essential oils), as well as their effect on liver exocretion. They increase the amount of secreted bile and the content of cholates in it, increase the osmotic gradient between bile and blood, which enhances the filtration of water and electrolytes into the bile capillaries, accelerate the flow of bile through the bile ducts, reduce the possibility of cholesterol precipitation, that is, they prevent the formation of gallstones, enhance the digestive and motor activity of the small intestine.

Drugs that promote bile secretion may act by stimulating contractions of the gallbladder (cholekinetics) or by relaxing the muscles of the biliary tract and sphincter of Oddi (cholespasmolytics).

Clinical classification of choleretic agents

(see Belousov Yu.B., Moiseev V.S., Lepakhin V.K., 1997)

[* - drugs or additives are marked, the drugs of which do not currently have valid registration in the Russian Federation.]

I. Drugs that stimulate bile formation - choleretics

A. Increasing the secretion of bile and the formation of bile acids (true choleretics):

1) preparations containing bile acids: Allohol, Cholenzym, Vigeratin, dehydrocholic acid (Hologon*) and sodium salt of dehydrocholic acid (Decholin*), Liobil*, etc.;

2) synthetic drugs: hydroxymethylnicotinamide (Nicodin), osalmide (Oxafenamide), cyclovalone (Cyqualon), hymecromone (Odeston, Holonerton*, Cholestil*);

3) preparations of plant origin: sandy immortelle flowers, corn silk, tansy (Tanacehol), rose hips (Holosas), Berberine bisulfate, birch buds, blue cornflower flowers, oregano herb, calamus oil, turpentine oil, peppermint oil, mackerel leaves (Flacumin), Far Eastern lily of the valley herb (Convaflavin), turmeric root (Phebihol*), buckthorn, etc.

B. Drugs that increase the secretion of bile due to the water component (hydrocholeretics): mineral waters, sodium salicylate, valerian preparations.

II. Drugs that stimulate bile secretion

A. Cholekinetics - increase the tone of the gallbladder and reduce the tone of the bile ducts: cholecystokinin*, magnesium sulfate, pituitrin*, choleritin*, barberry preparations, sorbitol, mannitol, xylitol.

B. Cholespasmolytics - cause relaxation of the biliary tract: atropine, platiphylline, methocinium iodide (Metacin), belladonna extract, papaverine, drotaverine (No-shpa), mebeverine (Duspatalin), aminophylline (Eufillin), Olimethine.

I.A.1) Preparations containing bile acids and bile- these are drugs containing either bile acids themselves, or combined drugs, which, in addition to lyophilized animal bile, may include extracts of medicinal plants, extract of liver tissue, pancreatic tissue and mucous membranes of the small intestine of cattle, activated carbon.

Bile acids, absorbed into the blood, stimulate the bile-forming function of hepatocytes, the unabsorbed part performs a replacement function. In this group, drugs that are bile acids increase the volume of bile to a greater extent, and drugs containing animal bile increase the content of cholates (bile salts) to a greater extent.

I.A.2) Synthetic choleretics have a pronounced choleretic effect, but do not significantly change the excretion of cholates and phospholipids into bile. After entering hepatocytes from the blood, these drugs are secreted into bile and dissociate, forming organic anions. The high concentration of anions creates an osmotic gradient between bile and blood and causes osmotic filtration of water and electrolytes into the bile capillaries. In addition to choleretic, synthetic choleretics have a number of other effects: antispasmodic (oxaphenamide, hymecromone), hypolipidemic (oxaphenamide), antibacterial (hydroxymethylnicotinamide), anti-inflammatory (cyclovalone), and also suppress the processes of putrefaction and fermentation in the intestines (especially hydroxymethylnicotinamide).

I.A.3) Effect herbal preparations associated with the influence of a complex of components included in their composition, incl. such as essential oils, resins, flavones, phytosterols, phytoncides, some vitamins and other substances. Drugs in this group increase the functional capacity of the liver, increase the secretion of bile, increase the content of cholates in bile (for example, immortelle, rose hips, Cholagol), and reduce the viscosity of bile. Along with increasing bile secretion, most herbal remedies in this group increase the tone of the gallbladder while simultaneously relaxing the smooth muscles of the biliary tract and sphincters of Oddi and Lutkens. Choleretic herbal remedies also have a significant effect on other functions of the body - they normalize and stimulate the secretion of the glands of the stomach and pancreas, increase the enzymatic activity of gastric juice, and enhance intestinal motility during atony. They also have antimicrobial (for example, immortelle, tansy, mint), anti-inflammatory (Olimethin, Cholagol, rosehip), diuretic, antimicrobial effects.

As medicinal preparations from plants, in addition to extracts and tinctures, infusions and decoctions from herbal collections are prepared. Usually take herbal medicines 30 minutes before meals, 3 times a day.

I.B. Hydrocholeretics. This group includes mineral waters - “Essentuki” No. 17 (highly mineralized) and No. 4 (weakly mineralized), “Jermuk”, “Izhevskaya”, “Naftusya”, “Smirnovskaya”, “Slavyanovskaya”, etc.

Mineral waters increase the amount of secreted bile and make it less viscous. The mechanism of action of choleretic drugs of this group is due to the fact that, being absorbed into the gastrointestinal tract, they are secreted by hepatocytes into primary bile, creating increased osmotic pressure in the bile capillaries and contributing to an increase in the aqueous phase. In addition, the reabsorption of water and electrolytes in the gallbladder and bile ducts decreases, which significantly reduces the viscosity of bile.

The effect of mineral waters depends on the content of sulfate anions (SO 4 2-), associated with magnesium (Mg 2+) and sodium (Na +) cations, which have a choleretic effect. Mineral salts also help to increase the colloidal stability of bile and its fluidity. For example, Ca 2+ ions, forming a complex with bile acids, reduce the likelihood of a sparingly soluble precipitate.

Mineral waters are usually consumed warm 20-30 minutes before meals.

Hydrocholeretics also include salicylates (sodium salicylate) and valerian preparations.

II.A. TO cholekinetics include drugs that increase the tone and motor function of the gallbladder and reduce the tone of the common bile duct.

The cholekinetic effect is associated with irritation of the receptors of the intestinal mucosa. This leads to a reflex increase in the release of endogenous cholecystokinin. Cholecystokinin is a polypeptide produced by the cells of the duodenal mucosa. The main physiological functions of cholecystokinin are to stimulate contraction of the gallbladder and the secretion of digestive enzymes by the pancreas. Cholecystokinin enters the blood, is captured by liver cells and secreted into the bile capillaries, while exerting a direct activating effect on the smooth muscles of the gallbladder and relaxing the sphincter of Oddi. As a result, bile enters the duodenum and its stagnation is eliminated.

Magnesium sulfate has a choleretic effect when taken orally. A solution of magnesium sulfate (20-25%) is prescribed orally on an empty stomach, and is also administered through a probe (for duodenal intubation). In addition, magnesium sulfate also has a cholespasmolytic effect.

Polyhydric alcohols (sorbitol, mannitol, xylitol) have both cholekinetic and choleretic effects. They have a beneficial effect on liver function, help normalize carbohydrate, lipid and other types of metabolism, stimulate bile secretion, cause the release of cholecystokinin, and relax the sphincter of Oddi. Polyhydric alcohols are used when performing duodenal intubation.

Olive and sunflower oils, plants containing bitterness (including dandelion, yarrow, wormwood, etc.), essential oils (juniper, caraway, coriander, etc.), extract and juice of cranberries, lingonberries and others also have a cholekinetic effect. etc.

II.B. TO cholespasmolytics include drugs with different mechanisms of action. The main effect of their use is the weakening of spastic phenomena in the biliary tract. m-Cholinolytics (atropine, platyphylline), by blocking m-cholinergic receptors, have a non-selective antispasmodic effect on various parts of the gastrointestinal tract, incl. in relation to the biliary tract.

Papaverine, drotaverine, aminophylline - have a direct (myotropic) effect on smooth muscle tone.

Other drugs also have a cholespasmolytic effect. However, they are rarely used as choleretic agents. Thus, nitrates relax the sphincter of Oddi, the lower esophageal sphincter, and reduce the tone of the biliary tract and esophagus. Nitrates are not suitable for long-term therapy, because have pronounced systemic side effects. Glucagon may temporarily decrease the tone of the sphincter of Oddi. But both nitrates and glucagon have a short-term effect.

Indications Choleretics are prescribed for chronic inflammatory diseases of the liver and biliary tract, incl. chronic cholecystitis and cholangitis, they are used for biliary dyskinesia, in the treatment of constipation. If necessary, choleretics are combined with antibiotics, analgesics and antispasmodics, and laxatives.

Unlike other choleretic drugs, drugs containing bile acids and bile are means of replacement therapy for endogenous bile acid deficiency.

Cholekinetics cause an increase in the tone of the gallbladder and relaxation of the sphincter of Oddi, so they are prescribed mainly for the hypotonic form of biliary dyskinesia. Indications for their use are atony of the gallbladder with stagnation of bile in dyskinesia, chronic cholecystitis, chronic hepatitis, in anacid and severe hypoacid conditions. They are also used during duodenal intubation.

Cholespasmolytics are prescribed for the hyperkinetic form of biliary dyskinesia and for cholelithiasis. They are used to relieve pain of moderate intensity, often accompanying pathology of the biliary tract.

Choleretics contraindicated at acute hepatitis, cholangitis, cholecystitis, pancreatitis, gastric and duodenal ulcers in the acute stage, cholelithiasis with obstruction of the excretory ducts, obstructive jaundice, as well as dystrophic lesions of the liver parenchyma.

Cholekinetics are contraindicated in acute liver diseases, in the presence of gallstones, in exacerbation of hyperacid gastritis and peptic ulcers of the stomach and duodenum.

Criteria for assessing the effectiveness and safety of the use of drugs used for impaired bile secretion:

- Laboratory: determination of bile acids in the blood and gallbladder bile (with pathology, the amount of bile acids in the blood increases, and in bile - decreases, the ratio between their three main forms - cholic, chenodeoxycholic, deoxycholic - and glycine and taurine conjugates changes), blood test (increased bile acids in blood leads to hemolysis, leukopenia, disrupts blood coagulation processes), determination in the blood of indirect and direct bilirubin, ALT, AST, bile pigments, etc.

- Paraclinical, incl. duodenal intubation, contrast cholecystography, ultrasound.

- Clinical: high concentrations of cholates in the blood cause bradycardia, arterial hypertension, skin itching, jaundice; symptoms of neurosis appear; pain in the right hypochondrium or epigastrium, enlarged liver.

TO drugs used for increased lithogenicity of bile(in the absence of stones), include Allohol, Cholenzym, hydroxymethylnicotinamide (Nicodin), sorbitol, Olimethine. The drugs in this group have different mechanisms of action, since the lithogenicity of bile depends on many factors.

Cholelitholytic agents(cm. ). A number of derivatives of deoxycholic acid, in particular ursodeoxycholic acid, isomeric chenodeoxycholic acid, can not only prevent the formation of cholesterol stones in the gall bladder, but also dissolve existing ones.

Cholesterol, which forms the basis of most gallstones, is normally found in a dissolved state in the center of micelles, the outer layer of which is formed by bile acids (cholic, deoxycholic, chenodeoxycholic). Phospholipids concentrated in the center of the micelle increase its ability to prevent cholesterol crystallization. A decrease in the content of bile acids in bile or an imbalance between the concentrations of phospholipids and cholesterol and a supersaturation of bile with cholesterol can lead to the fact that the bile becomes lithogenic, i.e. capable of forming cholesterol stones. Changes in the physicochemical properties of bile lead to the precipitation of cholesterol crystals, which then form a nucleus to form cholesterol gallstones.

Both ursodeoxycholic and chenodeoxycholic acids change the ratio of bile acids, reduce the secretion of lipids into bile and lower the cholesterol content in bile, reduce the cholate-cholesterol index (the ratio between the content of acids and cholesterol in bile), thereby reducing the lithogenicity of bile. They are prescribed as cholelitholytic agents in the presence of small cholesterol stones as an addition to surgical or shock wave treatments for cholelithiasis.

Drugs

Drugs - 1670 ; Trade names - 80 ; Active ingredients - 21

Active substance	Trade names
Information is absent

Solution in ampoules of 1 ml (5 units).

pharmachologic effect

Stimulation of labor.

Pharmacodynamics and pharmacokinetics

Pharmacodynamics

Pituitrin is a hormonal drug obtained from the pituitary gland of livestock. It contains hormones - oxytocin And vasopressin . Biological activity is determined by content oxytocin . Stimulates labor by causing uterine contractions. Has a vasoconstrictor effect and increases due to the presence vasopressin . The antidiuretic effect is manifested by an increase in water reabsorption in the kidneys.

Pharmacokinetics

Data not provided.

Indications for use

metrorrhagia ;
weakness of labor;
postpartum hemorrhage;
urinary incontinence;
diabetes insipidus .

Contraindications

increased sensitivity;
hypertonic disease ;
myocarditis ;
expressed;
sepsis ;
pregnant women;
scars on the uterus and the threat of its rupture.

Pituitrin should be used with caution.

Side effects

Pituitrin may cause:

fetus;
hypertonicity of the uterus;
promotion ;
bronchospasm .

Pituitrin, instructions for use (Method and dosage)

Pituitrin in the form of a solution is administered subcutaneously or intramuscularly. The highest single dose is 10 units.

For uterine bleeding and for contraction of the uterus after childbirth - 0.25 ml every 30 minutes, bringing to a total dose of 1 ml.

For quick delivery, 0.5-1.0 ml is used once in the second stage of labor.

At diabetes insipidus - 1 ml intramuscularly 1-2 times a day.

Overdose

There are no known cases of overdose.

Interaction

No data provided.

Terms of sale

Pituitrin is available by prescription.

Storage conditions

Temperature 1-8°C.

Best before date

Analogs

, Hyfotocin .

Reviews

The drug Pituitrin is maximally exempt from vasopressin , it is administered intravenously. Hyfotocin has less content vasopressin . Currently, these drugs are not found in pharmacies and are not used. There is an explanation for this. Synthetic oxytocin has the advantage that it has a more selective effect on the uterus, since it does not contain impurities of other hormones and does not significantly affect HELL . In addition, it is free from proteins and is used intravenously without fear of pyrogenic effects, therefore for many years it has been widely used in gynecological practice.

Pituitrinum

Pharmacological action of the drug.

The main active ingredients of pituitrin are oxytocin and vasopressin (pitressin). The first causes a contraction of the muscles of the uterus, the second causes a narrowing of the capillaries (the smallest vessels) and an increase in blood pressure, participates in regulating the constancy of the osmotic pressure of the blood (hydrostatic pressure), causing an increase in water reabsorption (reverse absorption) in the convoluted kidney canals and a decrease in chloride reabsorption.

What is it used for? Indications for use of the drug.

Used to stimulate and enhance the contractile activity of the uterus during primary and secondary weakness and distortion of pregnancy; hypotonic bleeding (bleeding caused by decreased uterine muscle tone) in the early postpartum period; to normalize uterine involution (reduction in the volume of the uterine body) in the postpartum and post-abortion periods. Diabetes insipidus (a disease caused by the absence or decrease in the secretion of antidiuretic / urination-reducing hormone). Bed-wetting.

Dosage and method of application.

The drug is administered subcutaneously or intramuscularly at 0.2-0.25 ml (1.0-1.25 units) every 15-30 minutes 4-6 times. To enhance the effect, you can combine pituitrin with intramuscular injection of estrogens (female sex hormones).
A single dose of pituitrin 0.5-1.0 ml (2.5-5 units) can be used in the second stage of labor if there are no obstacles to the advancement of the fetal head and rapid delivery.
To prevent and stop hypotonic bleeding in the early postpartum period, pituitrin is sometimes administered intravenously (1 ml - 5 units - in 500 ml of a 5% glucose solution) or very slowly (0.5-1 ml in 40 ml of a 40% glucose solution).
Due to the antidiuretic (reducing urine output) effect of the drug, it is also used for bedwetting and diabetes insipidus. Injected under the skin and into the muscles for adults: 1 ml (5 units), children under 1 year - 0.1-0.15 ml, 2-5 years - 0.2-0.4 ml, 6-12 years - 0.4-0.6 ml 1-2 times a day.
Higher doses for adults: single - 10 units, daily - 20 units.

Side effects and actions of the drug.

Large doses of pituitrin, especially when administered quickly, can cause spasms (sharp narrowing of the lumen) of cerebral vessels, circulatory disorders, and collapse (sharp drop in blood pressure).

Contraindications and negative properties.

Severe atherosclerosis, myocarditis (inflammation of the heart muscle), hypertension (persistent rise in blood pressure), thrombophlebitis (inflammation of the vein wall with blockage), sepsis (blood infection by microbes from the source of purulent inflammation), nephropathy (kidney disease) in pregnant women. The drug should not be prescribed if there are scars on the uterus, the threat of uterine rupture, or abnormal fetal position.

Release form. Package.

In ampoules of 1 ml containing 5 units.

Storage conditions and periods.

List B. In a dark place at a temperature from +1 to +10 ° C.

Composition and contents.

A hormonal preparation obtained from the posterior lobe of the pituitary gland of cattle and pigs.
Transparent colorless liquid of acidic reaction (pH 3.0 - 4.0).
Preserved with 0.25 - 0.3% phenol solution.
The main active ingredients of pituitrin are oxytocin and vasopressin (pitressin).
Pituitrin activity is standardized by biological methods; 1 ml of the drug should contain 5 units.

Active ingredients: Oxytocin, vasopressin

Important!

Description of the drug " Pituitrin"on this page is a simplified and expanded version of the official instructions for use. Before purchasing or using the drug, you should consult your doctor and read the instructions approved by the manufacturer.
Information about the drug is provided for informational purposes only and should not be used as a guide to self-medication. Only a doctor can decide to prescribe the drug, as well as determine the dose and methods of its use.