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Active Ingredient: Cabergoline.

Analogs of Dostinex:Cabgolin.

Other names for this medication:
Actualene, Agalates, Cabaser, Cabaseril, Cabergolek, Cabergolin, Cabergolina, Cabergolinum, Caberlin, Caberpar, Cabeser, Cabest, Cieldom, Galastop, Kabergolin, Lac stop, Lactamax, Lactovet, Prolastat, Sogilen, Sostilar, Triaspar.

Dostinex is used for treating disorders associated with high levels of the hormone prolactin, either due to tumors in the pituitary gland or to unknown causes.♀

Pharmachologic effect

Dopamine receptor agonist. Cabergoline is a dopaminergic ergoline derivative, characterized by a pronounced and prolonged prolactin-lowering effect. The mechanism of action is associated with direct stimulation of the dopamine D2 receptors of the lactotropic pituitary cells. In doses exceeding those to reduce the level of prolactin in the blood plasma, it has a central dopaminergic effect due to the stimulation of dopamine D2 receptors.

A decrease in the concentration of prolactin in the blood plasma is noted 3 hours after taking the drug and persists for 7-28 days in healthy volunteers and patients with hyperprolactinemia, and up to 14-21 days in women in the postpartum period. Prolactin-reducing action is dose-dependent both in terms of severity and duration of action.

Cabergoline has a strictly selective effect, does not affect the basal secretion of other pituitary and cortisol hormones.

Pharmacological effects of cabergoline, not related to the therapeutic effect, include only a decrease in blood pressure. With a single use of the drug, the maximum hypotensive effect is observed during the first 6 hours and is dose-dependent.


٭Suction and distribution

After oral administration, cabergoline is rapidly absorbed from the gastrointestinal tract. Cmax in plasma is achieved in 0.5-4 hours. Binding to plasma proteins is 41-42%. Css is achieved after 4 weeks of therapy due to prolonged T1 / 2.

Meal does not affect the absorption and distribution of cabergoline.


The main product of cabergoline metabolism identified in the urine is 6-allyl-8β-carboxy-ergoline at a concentration of up to 4-6% of the dose taken. The content in the urine of 3 additional metabolites does not exceed 3% of the dose. Metabolism products have a significantly lower effect in suppressing the secretion of prolactin compared to cabergoline.


T1 / 2, estimated by the rate of excretion by the kidneys, is 63-68 h in healthy volunteers and 79-115 h in patients with hyperprolactinemia.

10 days after taking the drug, 18% and 72% of the received dose are detected in the urine and feces, respectively, and the proportion of unchanged cabergoline in the urine is 2-3%.

☞prevention of physiological postpartum lactation;

☞suppression of established postpartum lactation;

☞treatment of disorders associated with hyperprolactinemia, including amenorrhea, oligomenorrhea, anovulation and galactorrhea;

☞prolactin-secreting pituitary adenomas (micro- and macroprolactinomas), idiopathic hyperprolactinemia, “empty” Turkish saddle syndrome in combination with hyperprolactinemia.

Dosing regimen📅
Is ingested, during meals.

Lactation prevention: 1 mg (2 tab.) Once on the first day after birth.

Suppression of established lactation: 0.25 mg (1/2 tab.) 2 times / day every 12 hours for 2 days (total dose is 1 mg). In order to reduce the risk of orthostatic hypotension in lactating mothers, a single dose of Dostinex should not exceed 0.25 mg.

Treatment of disorders associated with hyperprolactinemia: the recommended initial dose is 0.5 mg per week in 1 (1 tab.) Or 2 doses (1/2 tab., For example, on Monday and Thursday). Increasing the weekly dose should be carried out gradually – at 0.5 mg with an interval of 1 month to achieve the optimal therapeutic effect. The therapeutic dose is usually 1 mg per week, but can range from 0.25 mg to 2 mg per week. The maximum dose for patients with hyperprolactinemia is 4.5 mg per week.

Depending on tolerance, the weekly dose can be taken once or divided into 2 or more doses per week. The division of the weekly dose into several doses is recommended when prescribing the drug in a dose of more than 1 mg per week.

In patients with hypersensitivity to dopaminergic drugs, the likelihood of side effects can be reduced by starting Dostinex therapy at a lower dose (0.25 mg 1 time per week), followed by a gradual increase until the therapeutic dose is reached. To improve the tolerability of the drug in the event of severe side effects, a temporary dose reduction is possible, followed by a gradual increase, for example, by 0.25 mg per week every 2 weeks.

Side effect
In clinical studies using Dostinex to prevent physiological lactation (1 mg once) and to suppress lactation (0.25 mg every 12 hours for 2 days), approximately 14% of women had adverse reactions. When using Dostinex for 6 months at a dose of 1-2 mg per week, divided into 2 doses, for the treatment of disorders associated with hyperprolactinemia, the incidence of adverse reactions was 68%. Adverse reactions occurred mainly during the first 2 weeks of therapy and in most cases disappeared as therapy continued or several days after discontinuation of the drug Dostinex. Adverse reactions were usually transient, mild or moderate in severity and dose-dependent. At least once during the course of therapy, severe side effects were observed in 14% of patients; due to adverse reactions, treatment was discontinued in approximately 3% of patients.

The most frequent adverse reactions are presented below.

☁Since the cardiovascular system: heartbeat; rarely, orthostatic hypotension (with prolonged use, the drug has a hypotensive effect); asymptomatic decrease in blood pressure during the first 3-4 days after birth (systolic – more than 20 mm Hg, diastolic – more than 10 mm Hg).

☁Nervous system disorders: dizziness / vertigo, headache, fatigue, drowsiness, depression, asthenia, paresthesias, syncope, nervousness, anxiety, insomnia, impaired concentration.

☁On the part of the digestive system: nausea, vomiting, epigastric pain, abdominal pain, constipation, gastritis, dyspepsia, dryness of the oral mucosa, diarrhea, flatulence, toothache, sensation of irritation of the pharyngeal mucosa.

☁Other: mastodynia, nasal bleeding, flushing to the skin of the face, transient hemianopia, vascular spasms of the fingers, muscle cramps of the lower extremities (like other ergot derivatives, Dostinex may have a vasoconstrictor effect), blurred vision, flu-like symptoms, malaise, periorbital and peripheral swelling, anorexia, acne, pruritus, joint pain.

🌞With long-term therapy with the use of the drug Dostinex, deviation from the norm of standard laboratory parameters was rarely observed; in women with amenorrhea, a decrease in hemoglobin level was observed during the first few months after the recovery of menstruation.🌞

☁The following adverse reactions associated with the use of cabergoline were registered in the post-marketing study: alopecia, increased blood CPK activity, mania, dyspnea, edema, fibrosis, abnormal liver function, abnormal liver function, hypersensitivity, rash, respiratory disorders, respiratory failure, valvulopathy, pathological addiction to gambling, hypersexuality, increased libido, aggressiveness, psychotic disorders, pericarditis, bouts of sudden sleep, decrease or increase in body weight, nasal congestion.

🍓Hypersensitivity to cabergoline or other components of the drug, as well as to any ergot alkaloids;

🍓dysfunction of the heart and respiration due to fibrous changes or the presence of such conditions in history;

🍓during long-term therapy: anatomical signs of valvular pathology of the heart (such as thickening of the valve leaflet, narrowing of the valve lumen, mixed pathology of narrowing and stenosis of the valve), confirmed by echocardiography (EchoCG), conducted before the start of therapy;

🍓lactose intolerance, lactase deficiency, glucose-galactose malabsorption;

🍓children and adolescents under 16 years of age (safety and efficacy have not been established).

Dostinex should be administered with caution in the following conditions and / or diseases:

🍓arterial hypertension that developed during pregnancy, for example, preeclampsia or postpartum arterial hypertension (Dostinex is prescribed only in cases where the potential benefit from the use of the drug significantly exceeds the possible risk);

🍓severe cardiovascular diseases, Raynaud’s syndrome;

🍓peptic ulcer, gastrointestinal bleeding;

🍓severe liver failure (the use of lower doses is recommended);

🍓severe psychotic or cognitive impairment (including in history);

🍓simultaneous use with drugs that have a hypotensive effect (due to the risk of orthostatic hypotension).

Use during pregnancy and lactation
Since there have been no controlled clinical trials with the use of the drug Dostinex in pregnant women, the prescription of the drug during pregnancy is possible only in cases of emergency, when the expected benefit to the mother outweighs the potential risk to the fetus.

If pregnancy has occurred on the background of treatment with Dostinex, the feasibility of discontinuing the drug should be considered, also taking into account the benefit / risk ratio.

According to available data, the use of Dostinex in a dose of 0.5-2 mg per week for disorders associated with hyperprolactinemia was not accompanied by an increase in the frequency of miscarriages, premature birth, multiple pregnancy and congenital malformations.

There is no information about the release of the drug in breast milk, however, in the absence of the effect of using the drug Dostinex to prevent or suppress lactation, breastfeeding should be abandoned. For disorders associated with hyperprolactinemia, Dostinex should not be prescribed to mothers who do not want to stop lactation.

Application for violations of the liver
With caution, use the drug in severe liver failure (lower doses are recommended).

Use in children
Contraindications: children and adolescents under 16 years of age (safety and efficacy have not been established).

Special instructions
Before prescribing Dostinex for the purpose of treating disorders associated with hyperprolactinemia, it is necessary to conduct a full study of the function of the pituitary gland.

In addition, the state of the cardiovascular system, including echocardiography, should be assessed in order to detect valvular dysfunction asymptomatic.

As with the use of other ergot derivatives, pleural effusion / pleural fibrosis and valvulopathy were observed in patients after long-term administration of cabergoline. In some cases, patients received prior therapy with dopamine ergotonin agonists. Therefore, Dostinex should not be used in patients with existing signs and / or clinical symptoms of dysfunction of the heart or respiration associated with fibrotic changes or with such a history. The drug should be discontinued if there are signs of the appearance or worsening of blood regurgitation, narrowing of the lumen of the valves or thickening of the valve leaflets.

It was found that ESR increases with the development of pleural effusion or fibrosis. If an unexplained increase in ESR is detected, a chest X-ray is recommended. A study of the concentration of creatinine in the blood plasma and an assessment of renal function can also help in the diagnosis. After discontinuation of Dostinex in patients with pleural effusion / pleural fibrosis or valvulopathy, symptoms improved.

It is not known whether cabergoline can worsen the condition of patients with signs of blood regurgitation. Cabergoline should not be used in the detection of fibrous lesions of the valvular apparatus of the heart.

Fibrotic disorders can develop asymptomatically. In this regard, the condition of patients receiving long-term treatment with cabergoline should be regularly monitored and special attention should be paid to the following symptoms:

☞pleural-pulmonary disorders: such as shortness of breath, difficulty breathing, persistent cough or chest pain;

☞renal failure or obstruction of the vessels of the ureters or abdominal organs, which may be accompanied by pain in the side or lumbar region and edema of the lower extremities, any swelling or tenderness in the abdominal region, which may indicate the development of retroperitoneal fibrosis;

☞pericardial fibrosis and fibrosis of the valves of the heart often manifest heart failure. In this regard, it is necessary to exclude fibrosis of the valves of the heart (and constrictive pericarditis) at the onset of symptoms of heart failure.

It should regularly monitor the patient’s condition for the development of fibrotic disorders. The first time EchoCG should be performed 3-6 months after the start of therapy. Then this study should be conducted depending on the clinical assessment of the patient’s condition, paying particular attention to the symptoms described above, at least every 6-12 months of therapy.

The need for other monitoring methods (for example, physical examination, including auscultation of the heart, radiography, computed tomography) is assessed individually for each patient.

With increasing doses, patients should be under the supervision of a physician in order to establish the minimum effective dose that provides a therapeutic effect.

After an effective dosing regimen is selected, it is recommended to regularly (once a month) determine the serum prolactin concentration. Normalization of prolactin concentration is usually observed within 2-4 weeks of treatment.

After discontinuation of Dostinex, there is usually a relapse of hyperprolactinemia, however, in some patients persistent inhibition of prolactin concentration is observed for several months. In most women, ovulatory cycles persist for at least 6 months after discontinuation of Dostinex.

Dostinex restores ovulation and fertility in women with hyperprolactinemic hypogonadism. Since pregnancy can occur before menstruation is restored, it is recommended that pregnancy tests be performed at least once every 4 weeks during the amenorrhea period, and after menstruation is restored – every time there is a delay in menstruation for more than 3 days. Women who want to avoid pregnancy should use barrier methods of contraception during treatment with Dostinex, as well as after discontinuation of the drug before repeating anovulation. Women who have become pregnant should be supervised by a physician in order to identify the symptoms of an increase in the pituitary gland in a timely manner, since an increase in the size of existing pituitary tumors is possible during pregnancy.

Dostinex should be administered in lower doses to patients with severe hepatic insufficiency (Child-Pugh class C), who have been given prolonged therapy with the drug. With a single dose of 1 mg in these patients, an increase in AUC was observed compared with healthy volunteers and patients with less severe hepatic insufficiency.

The use of cabergoline causes drowsiness. In patients with Parkinson’s disease, the use of dopamine receptor agonists can cause sudden sleep. In such cases, it is recommended to reduce the dose of the drug Dostinex or discontinue therapy.

Studies on the use of the drug in elderly patients with disorders associated with hyperprolactinemia, was not conducted.

Use in Pediatrics

The safety and efficacy of the drug in children and adolescents under 16 years of age has not been established.

Influence on ability to drive motor transport and control mechanisms

Patients taking the drug Dostinex should refrain from driving vehicles and mechanisms and other potentially dangerous activities requiring concentration of attention and speed of psychomotor reactions.


Symptoms (more likely, symptoms of dopamine receptor hyperstimulation): nausea, vomiting, dyspeptic symptoms, orthostatic hypotension, confusion, psychosis, hallucinations.

Treatment: should carry out activities aimed at removing the drug (gastric lavage) and to maintain blood pressure. The use of dopamine antagonists is recommended.

Drug interaction

Information about the interaction of cabergoline and other ergot alkaloids is absent, therefore the simultaneous use of these drugs during long-term therapy with Dostinex is not recommended.

Since cabergoline has a therapeutic effect by direct stimulation of dopamine receptors, the drug cannot be administered simultaneously with drugs acting as dopamine antagonists (including phenothiazines, butyrophenones, thioxanthenes, metoclopramide), because they can weaken the effect of cabergoline, aimed at reducing the concentration of prolactin.

Like other ergot derivatives, cabergoline cannot be used simultaneously with macrolide antibiotics (for example, with erythromycin), since this can lead to an increase in the system bioavailability of cabergoline.

Terms and conditions of storage
The drug should be stored out of reach of children at a temperature not exceeding 25 ° C. Shelf life – 2 years.

Pharmacy sales terms
The drug is available without a prescription.

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Active Ingredient: Anastrozole.

Arimidex is used for treating breast cancer in women who have been through menopause, including women with disease progression after tamoxifen therapy. ⇜

Other names for this medication:
Anastrol, Anastrozolo, Anastrozolum, Armidex.

Clinico-pharmacological group
Antitumor drug. Aromatase Inhibitor.

Pharmachologic effect
Highly selective nonsteroidal aromatase inhibitor. Aromatase is an enzyme with which in postmenopausal women, androstenedione in peripheral tissues is converted into estrone and then into estradiol. Reducing circulating estradiol has a therapeutic effect in patients with breast cancer. In postmenopausal medication in a daily dose of 1 mg causes a decrease in estradiol levels by 80%.

Arimidex does not possess progestogenic, androgenic and estrogenic activity.

Arimidex in a daily dose of up to 10 mg has no effect on the secretion of cortisol and aldosterone (therefore, the use of the drug does not require the replacement of corticosteroids).


After oral administration, anastrozole is rapidly absorbed from the gastrointestinal tract. Cmax in plasma is reached within 2 hours (on an empty stomach). Food somewhat reduces the rate, but not the degree of absorption. Small changes in the rate of absorption do not lead to a clinically significant effect on the Css of the drug in plasma with a daily intake of 1 tab. Arimidex.

Anastrozole is associated with plasma proteins by 40%. Approximately 90-95% of Сss is achieved after 7 days of taking the drug. There is no information about the cumulation of the drug and the dependence of the pharmacokinetic parameters of anastrozole on time and dose.

Anastrozole is metabolized by N-dealkylation, hydroxylation and glucuronization. Triazole, the major metabolite detected in plasma, does not inhibit aromatase.

Anastrozole is displayed slowly, T1 / 2 – 40-50 h.

Anastrozole and its metabolites are excreted mainly with urine (less than 10% of the excreted dose – unchanged), within 72 hours after taking the drug.

Pharmacokinetics in special clinical situations

The determined clearance of anastrozole after oral administration in volunteers with stabilized liver cirrhosis or renal dysfunction does not differ from clearance determined in healthy volunteers.

Anastrozole pharmacokinetics does not depend on age in postmenopausal women.

☞adjuvant therapy for early hormone-positive breast cancer in postmenopausal women;

☞treatment of advanced breast cancer in postmenopausal women;

☞adjuvant therapy for early hormone-positive breast cancer in postmenopausal women after tamoxifen therapy for 2–3 years.


☞renal failure severe (creatinine clearance less than 20 ml / min);

☞moderate and severe liver failure (safety and efficacy not established);

☞concomitant therapy with tamoxifen;

☞children’s age (safety and efficacy not established);


☞lactation (breastfeeding);

☞Hypersensitivity to anastrozole and other components of the drug.

The drug is not prescribed to women in premenopausal women.

Adults, including elderly patients, the drug is prescribed 1 mg orally 1 time / day, long-term. If there is evidence of disease progression, the drug should be discontinued. As adjuvant therapy, the recommended duration of treatment is 5 years.

Patients with mild and moderately severe renal impairment do not require dose adjustment.

Patients with mild hepatic impairment do not require dose adjustment.

The tablet should be swallowed whole and washed down with water. It is recommended to take the drug at the same time of day.

Side effects
👣 Determination of the frequency of adverse reactions: very often (> 10%); often (1-10%); rarely (0.1-1%); very rarely (<0.1%).

👣 Since the cardiovascular system: very often – tides.

👣 From the musculoskeletal system: often – arthralgia.

👣 Reproductive system: often – vaginal dryness; rarely, vaginal bleeding (mainly during the first weeks after the cancellation or change of previous hormonal therapy with Arimidex).

👣 On the part of the digestive system: often – nausea, diarrhea; rarely – anorexia, vomiting, increased activity of GGT and alkaline phosphatase.

👣 On the part of the nervous system: often – headache, carpal tunnel syndrome (mainly observed in patients with risk factors for this disease); rarely – drowsiness.

👣 Metabolism: rarely – hypercholesterolemia. The drug may cause a decrease in bone mineral density due to a decrease in circulating estradiol, thereby increasing the risk of osteoporosis and bone fractures.

👣 Dermatological reactions: often – thinning hair, skin rash; very rarely – erythema multiforme (Stevens-Johnson syndrome).

👣 Allergic reactions: very rarely – angioedema, urticaria, anaphylactic shock.

👣 Other: often – asthenia.

Single clinical cases of drug overdose are described. A single dose of Arimidex, at which life-threatening symptoms develop, has not been established.

Treatment: there is no specific antidote. If necessary, carry out symptomatic therapy: induction of vomiting (if the patient is conscious), general supportive therapy, monitoring the patient and monitoring the function of vital organs and systems. Dialysis is possible.

Drug interaction
Clinical studies on drug interactions with antipyrine and cimetidine indicate that co-administration of Arimidex with other drugs is unlikely to lead to a clinically significant interaction due to cytochrome P450.

There is no clinically significant drug interaction when taking Arimidex at the same time as other frequently prescribed drugs.

At the moment there is no information on the use of Arimidex in combination with other anticancer drugs.

Estrogen containing preparations should not be administered concurrently with Arimidex, since they reduce the pharmacological effect of the latter.

Tamoxifen should not be given at the same time as Arimidex, since it may weaken the pharmacological action of the latter.

Special instructions
In women with a receptor-negative estrogen tumor, the efficacy of Arimidex has not been demonstrated, unless there was a prior positive clinical response to tamoxifen.

In case of doubts about the hormonal status of the patient, the menopause must be confirmed by determining the sex hormones in the blood serum.

There are no data on the safety of Arimidex in patients with severe liver dysfunction or in patients with severe renal insufficiency (CC less than 20 ml / min).

In case of persistent uterine bleeding while receiving Arimidex, consultation and supervision of a gynecologist is necessary.

Drugs containing estrogen should not be administered simultaneously with Arimidex.

By lowering the level of circulating estradiol, Arimidex can cause a decrease in bone mineral density.

In patients with osteoporosis or with the risk of osteoporosis, bone mineral density should be assessed by means of densimetry (for example, DEXA scan) at the beginning of treatment and over time. If necessary, treatment or prevention of osteoporosis should be initiated under the close supervision of a physician.

There is no data on the simultaneous use of anastrozole and preparations of GnRH analogues.

It is not known whether anastrozole improves the results of treatment when used in combination with chemotherapy.

Safety data for long-term treatment with anastrozole has not yet been obtained.

With the use of Arimidex, ischemic diseases were observed more frequently than with tamoxifen therapy, but no statistical significance was noted.

The efficacy and safety of Arimidex and tamoxifen, when applied simultaneously, regardless of the status of hormone receptors, are comparable to those of tamoxifen alone. The exact mechanism of this phenomenon is not yet known.

Use in Pediatrics

Safety and efficacy of the drug in children have not been established.

Influence on ability to drive motor transport and control mechanisms

Some side effects of Arimidex, such as asthenia and drowsiness, may adversely affect the ability to perform work that requires increased concentration of attention and quickness of psychomotor reactions. In this regard, it is recommended that when these symptoms appear, caution should be exercised when driving a car or moving machinery.

Pregnancy and lactation
The drug is contraindicated for use during pregnancy and lactation (breastfeeding).

Use in childhood
The drug is contraindicated for use in children (safety and efficacy not established).

In case of impaired renal function
Patients with mild and moderately severe renal impairment do not require dose adjustment.

Contraindicated in severe renal failure (creatinine clearance less than 20 ml / min).

With abnormal liver function
Patients with mild hepatic impairment do not require dose adjustment.

Contraindicated in moderate or severe liver failure (safety and efficacy not established).

Pharmacy sales terms
The drug is available without a prescription.

Terms and conditions of storage
The drug should be stored out of reach of children at a temperature not exceeding 30 ° C. Shelf life – 5 years.