Knowrem - Instructions For The Use Of Tablets, Price, Analogs, Reviews

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

Knowrem

Knowrem: 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. Use in the elderly
13. 13. Drug interactions
14. 14. Analogs
15. 15. Terms and conditions of storage
16. 16. Terms of dispensing from pharmacies
17. 17. Reviews
18. 18. Price in pharmacies

Latin name: Nourem

ATX code: H01BA02

Active ingredient: desmopressin (Desmopressin)

Producer: CJSC "Kanonfarma Production" (Russia)

Description and photo update: 2019-21-09

Prices in pharmacies: from 1269 rubles.

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Nourem - a remedy for the treatment of diabetes insipidus; antidiuretic.

Release form and composition

Dosage forms of Nourem:

• tablets: round, flat-cylindrical (100 mcg), biconvex (200 mcg), almost white or white (10 pcs. in a blister, in a cardboard box 3 or 6 packs; 30 pcs. in a blister, in a cardboard box pack 1, 2, 3 or 4 packages);
• sublingual tablets: round, biconvex, with a cross-shaped line (240 μg), almost white or white (10 or 30 pcs. in a blister strip; in a cardboard box 1 or 3 packs).

Each pack also contains instructions for the use of Nourem.

1 tablet contains:

• active substance: desmopressin acetate - 100 or 200 μg (in the form of trihydrate 105 or 210 μg), in terms of desmopressin 89 or 178 μg;
• additional components: sodium carboxymethyl starch, pregelatinized corn starch, mannitol, microcrystalline cellulose, magnesium stearate.

1 sublingual tablet contains:

• active substance: desmopressin acetate (in the form of trihydrate) - 67, 135 or 270 μg, in terms of desmopressin 60, 120 or 240 μg;
• additional components: calcium stearate, lemon flavoring, mannitol, maltodextrin, F-MELT type C (D-mannitol ÷ xylitol ÷ microcrystalline cellulose ÷ crospovidone ÷ calcium hydrogen phosphate anhydrous - 65 ÷ 5 ÷ 18 ÷ 8 ÷ 4).

Pharmacological properties

Pharmacodynamics

Desmopressin is a structural analogue of the natural peptide hormone of the hypothalamus - arginine-vasopressin, obtained through changes in the structure of the vasopressin molecule. These changes consist in the deamination of cysteine (in position 1) and the replacement of L-arginine with D-arginine (in position 8). This leads to a significant increase in the antidiuretic effect, and a complete lack of effect on the smooth muscles of internal organs and vascular walls when compared with native arginine-vasopressin.

In contrast to vasopressin, Nourem has a longer effect and does not provoke an increase in blood pressure (BP). It enhances the permeability of the epithelium of the distal convoluted tubules of the nephron for water and activates its reabsorption, which in turn provides a decrease in the volume of excreted urine while increasing its osmolarity and lowering the osmolarity of blood plasma. These phenomena cause a decrease in the frequency of urination and a decrease in the severity of nocturnal polyuria (nocturia).

After oral administration of tablets, the antidiuretic effect is noted already after 15 minutes and reaches its maximum after 4-7 hours. When using tablets at a dose of 0.1-0.2 mg, the antidiuretic effect is recorded up to 8 hours, at a dose of 0.4 mg - up to 12 h.

Pharmacokinetics

For oral administration of tablets, the absolute bioavailability can vary from 0.08 to 0.16%. Bioavailability of Nourem in sublingual form in doses of 0.2; 0.4 and 0.8 mg is approximately 0.25%. Its value can vary from patient to patient. Since the drug is a polypeptide, it is destroyed by the action of digestive enzymes of the gastrointestinal tract (GIT).

Concomitant oral administration of the drug with food can reduce the absorption rate by 40%. The active substance is detected in the blood 15-30 minutes after oral administration, the period of reaching the maximum concentration (C _max) in the blood plasma (T _Cmax) is 2 hours.

After sublingual administration of T _{Cmax of} desmopressin in plasma is 0.5–2 hours, the value of C _{max is} directly proportional to the dose used and after administration is 0.2; 0.4 and 0.8 mg is 14, 30 and 65 pg / ml, respectively.

The volume of distribution after oral administration reaches 0.2-0.3 l / kg.

The active substance does not cross the blood-brain barrier. According to the results of an in vitro study of liver microsomes, desmopressin is metabolized in a small amount in the liver, but this process in vivo is not significant.

The drug is excreted by the kidneys partially after enzymatic cleavage, partially - in an unchanged form, the half-life (T _1/2) is 2-3 hours.

Indications for use

• diabetes insipidus of central genesis;
• primary nocturnal enuresis in adults and children over 5 years of age;
• nocturnal polyuria in adults (for tablets), as a drug for symptomatic treatment;
• polyuria / polydipsia after hypophysectomy (surgical removal / destruction of the pituitary gland) or surgeries in the sella turcica (for sublingual tablets);
• nocturia in adults due to nocturnal polyuria (increased urine production at night, exceeding the volume of the bladder and leading to the need to get up at night more than 1 time to empty it) (for sublingual tablets), as symptomatic therapy.

Contraindications

Absolute:

• suspected or known chronic heart failure (CHF) and other conditions requiring the appointment of diuretics;
• habitual or psychogenic polydipsia (sublingual tablets - with a urine output of 40 ml / kg / 24 h);
• hyponatremia, (including in the anamnesis - for tablets), with a plasma level of sodium ions in the blood below 135 mmol / l;
• renal failure of moderate and severe severity, with creatinine clearance (CC) below 50 ml / min;
• polydipsia for chronic alcoholism - for sublingual tablets;
• children's age: tablets - up to 4 years (for the treatment of diabetes insipidus) and up to 5 years (for the treatment of primary nocturnal enuresis); sublingual tablets - up to 5 years;
• age 65 years and older - with sublingual use for the purpose of symptomatic treatment of nocturia;
• syndrome of inadequate production of antidiuretic hormone (ADH);
• hypersensitivity to desmopressin or to any auxiliary ingredient in the drug.

Relative (use Nourem with extreme caution, adjusting the dose if necessary):

• fibrosis of the bladder;
• renal failure, with CC more than 50 ml / min;
• diseases of the cardiovascular system, including ischemic heart disease (IHD) and arterial hypertension;
• potential risk of increased intracranial pressure;
• violations of water and electrolyte balance;
• the period of pregnancy, including with gestosis of the second half of pregnancy (preeclampsia);
• age 65 years and older (with sublingual administration - for the treatment of diabetes insipidus).

Additional relative contraindications for Nourem tablets: bronchial asthma, epilepsy, a history of migraine.

Additional relative contraindications for sublingual Nourem tablets: risk of thrombosis, cystic fibrosis.

Nourema, instructions for use: method and dosage

Nourem tablets are intended for oral administration.

Sublingual Nourem tablets are used sublingually - strictly under the tongue. You cannot take a sublingual tablet with liquid.

The optimal dose is selected individually. It is necessary to take the drug some time after a meal, since the simultaneous intake with food can lead to a decrease in its absorption and effectiveness.

Dose ratios between the two dosage forms of the drug: tablets at a dosage of 100, 200 and 400 mcg are equivalent to sublingual tablets at a dosage of 60, 120 and 240 mcg, respectively.

Recommended dosage regimen of Nourem:

• diabetes insipidus of central genesis and (sublingual form) polyuria / polydipsia after hypophysectomy: at the beginning of the course, the optimal dose of the drug is set by the doctor individually, depending on the osmolarity and urine volume, during therapy it is required to control the sleep period and water-electrolyte balance; the initial dose for children and adults is 1-3 times a day, 100 mcg orally or 3 times a day, 60 mcg sublingually, in the future the dose is adjusted taking into account the response to therapy; the daily dose is in the range of 200-1200 mcg (tablets) or 120-720 mcg (sublingual tablets); the optimal maintenance dose, as a rule, is 1–3 times a day, 100–200 mcg orally, or 3 times a day, 60–120 mcg sublingually;
• Primary nocturnal enuresis: Initial dose, at bedtime, 200 mcg orally or 120 mcg sublingually; in the absence of an effect, the dose of tablets can be increased to 400 μg, sublingual tablets - up to 240 μg, while it is necessary to control fluid intake in the evening; the course of continuous therapy is 3 months, the decision to extend the treatment is made taking into account the clinical data observed within 7 days after the cancellation of Nourem;
• nocturia in adults (tablets), nocturia in adults (sublingual tablets): initial dose, at night - 100 mcg orally or 60 mcg sublingually; in the absence of the desired effect for 7 days, the dose of tablets can be increased to 200 mcg, sublingual tablets - up to 120 mcg, then, with the frequency of use of the drug no more than 1 time in 7 days, the maximum dose should not exceed 400 mcg when taken orally and 240 mcg - with sublingual; the threat of fluid retention in the body should be taken into account, if after 28 days of therapy and dose adjustment it was not possible to achieve the appropriate clinical effect, the subsequent administration of Nourem is inappropriate.

If signs of fluid retention / hyponatremia develop during therapy, it is necessary to stop using Nourem or adjust the dose received.

Side effects

Adverse reactions recorded in adults during a clinical study in patients with nocturia (in the amount of 1557 people) and with post-registration use of Nourem for all indications (including diabetes insipidus):

• metabolism and nutritional disorders: often - hyponatremia; with an unknown frequency - hypernatremia *, dehydration *;
• immune system: with unknown frequency - anaphylactic reactions;
• nervous system: very often - headache; often - dizziness; infrequently - drowsiness, paresthesia; with an unknown frequency - asthenia *, convulsions, coma;
• organ of vision: infrequently - decreased visual acuity;
• mental disorders: infrequently - insomnia; rarely - confusion of consciousness;
• organ of hearing and labyrinthine disorders: infrequently - vertigo;
• vessels: often - arterial hypertension; infrequently - orthostatic hypotension;
• heart: infrequently - palpitations;
• Gastrointestinal tract: often - vomiting, abdominal pain, nausea, diarrhea / constipation; infrequently - bloating; flatulence, dyspepsia;
• respiratory system, organs of the chest and mediastinum: infrequently - shortness of breath;
• musculoskeletal system and connective tissue: infrequently - myalgia, muscle spasms;
• skin and subcutaneous tissues: infrequently - itching, urticaria, skin rash, increased sweating; rarely - allergic dermatitis;
• kidneys and urinary tract: often - urinary disorders, bladder dysfunction;
• instrumental and laboratory data: infrequently - an increase in body weight, increased activity of liver enzymes, hypokalemia;
• general disorders: often - a feeling of fatigue, peripheral edema; infrequently - flu-like syndrome, discomfort, chest pain.

* violations observed only in patients with diabetes insipidus.

Undesirable effects registered in children (in the amount of 1923 children) during a clinical study and in the process of post-registration use of Nourem for the treatment of primary nocturnal enuresis:

• respiratory system: with an unknown frequency - epistaxis;
• immune system: with unknown frequency - anaphylactic reactions;
• mental disorders: infrequently - a manifestation of aggression, emotional lability; rarely - a sharp change in mood, nightmares, anxiety; with an unknown frequency - insomnia, behavioral changes, emotional disorders, hallucinations, depression;
• vessels: rarely - arterial hypertension;
• nervous system: often - headache; rarely - drowsiness; with an unknown frequency - attention disorders, seizures, psychomotor hyperactivity;
• Gastrointestinal tract: infrequently - diarrhea, nausea, stomach pain, vomiting;
• kidneys and urinary tract: infrequently - impaired urination, impaired bladder function;
• metabolism and nutritional disorders: with an unknown frequency - hyponatremia;
• skin and subcutaneous tissues: with an unknown frequency - increased sweating, skin rash, urticaria, allergic dermatitis;
• general disorders: infrequently - a feeling of fatigue, peripheral edema; rarely - irritability.

It must be remembered that desmopressin is capable of exerting an antidiuretic effect. The use of Nourem without concomitant restriction of fluid intake can lead to its retention in the body and the occurrence of hyponatremia, manifested by the following symptoms: increased body weight, headache, malaise, nausea, vomiting, abdominal pain, dizziness, confusion; in severe cases - convulsions, cerebral edema, coma. The threat of the above complications is especially high in children under the age of 1 year or in elderly patients, depending on the general state of health.

In adults, during the therapy of nocturia, most often hyponatremia may occur at the beginning of the course or with an increase in the dose, this complication is reversible. Against the background of the use of Nourem, it is necessary to monitor the water and electrolyte balance. As a result of fluid retention during treatment, arterial hypertension may appear. Patients with coronary heart disease are at risk of developing angina pectoris.

Overdose

The threat of overdose is most likely when using Nourem in excessively high doses or when drinking too much fluid at the same time as taking the drug or shortly after.

Overdose symptoms are: nausea, weight gain due to fluid retention, headache; overhydration, which may be accompanied by seizures and confusion or loss of consciousness.

In this condition, it is necessary to reduce the dose of desmopressin, increase the period between doses throughout the day, or stop treatment with Nourem, depending on the severity of the overdose.

In case of suspicion of cerebral edema, urgent hospitalization is required, with the development of seizures, immediate intensive care is necessary. There is no specific antidote. In order to induce diuresis, diuretics (furosemide) are prescribed with simultaneous monitoring of the plasma level of electrolytes in the blood.

special instructions

To prevent the development of undesirable side effects, it is necessary to reduce fluid intake to a minimum 1 hour before taking Nourem and for 8 hours after taking it in patients with primary nocturnal enuresis.

In order to diagnose nocturnal polyuria, 2 days before the start of the course of therapy in patients with nocturia, it is necessary to monitor the volume and frequency of urination.

An increase in urine production recorded at night, which exceeds 1/3 of the daily urine volume or exceeds the volume of the bladder, is considered nocturnal polyuria.

When using Nourem for the treatment of nocturnal enuresis, cases of seizures and cerebral edema were recorded in healthy children and adolescents. In the first 7 days of the course, there is the highest probability of developing these complications.

It is necessary to increase the dose of Nourem with great caution due to the threat of hyponatremia.

If, during therapy, vomiting, diarrhea, systemic infectious lesions occur and body temperature rises, you should stop using the drug and limit fluid intake. It is possible to resume treatment with Nourem only after the elimination of violations of the water-electrolyte balance.

During therapy, it is recommended to control changes in body weight.

Before starting the course, it is necessary to exclude possible organic causes of the development of polyuria, an increase in urine volume or the appearance of nocturia, such as nephrolithiasis, urinary tract infections, prostatic hyperplasia, dysfunction of the bladder sphincter, bladder neoplasms, polydipsia or impaired glycemic control in patients with diabetes mellitus …

Influence on the ability to drive vehicles and complex mechanisms

Currently, there is no data on the possible effect of the drug on the patient's cognitive functions, ability to concentrate and reaction speed. However, it should be borne in mind that when using Nourem, the development of such disorders from the nervous system as headache and dizziness is likely. Therefore, it is recommended to exercise caution when driving vehicles and working with complex and potentially dangerous equipment.

Application during pregnancy and lactation

Strictly controlled and adequate studies of the safety of using Nourem during pregnancy and lactation have not been conducted.

According to the limited data available on the use of Nourem in pregnant women with diabetes insipidus, the negative effects of desmopressin on the course of pregnancy, the health of the mother, fetus and newborn were not recorded. In the process of preclinical studies on animals, there was also no direct / indirect effect on the course of pregnancy, childbirth, intrauterine and postnatal development of the fetus / child. Despite this information, Nourem should be used by pregnant women only when the intended benefit of therapy significantly outweighs the possible threat to the fetus. The dosage regimen in this category of patients must be adjusted depending on the condition. Given the increased risk of preeclampsia, blood pressure should be monitored.

In a study of breast milk in women who took intranasally desmopressin at a dose of 300 μg, it was found that Nourem can enter the child's body only in very small quantities and, as a result, is not able to influence his diuresis.

Pediatric use

Nourem in the form of sublingual tablets cannot be used by children under 5 years of age.

It is contraindicated to take tablets for the treatment of diabetes insipidus in children under 4 years of age, for the treatment of primary nocturnal enuresis - in children under 5 years of age.

With impaired renal function

In the presence of moderate and severe renal failure (CC below 50 ml / min), use of Nurem is contraindicated, in case of mild (CC more than 50 ml / min), the drug should be used with caution.

Use in the elderly

Elderly patients aged 65 years and older are contraindicated in taking Nourem sublingual tablets for symptomatic treatment of nocturia. Patients of this age group need to take the drug orally, as well as sublingually for the treatment of diabetes insipidus, with extreme caution, since they have an increased risk of adverse reactions, including fluid retention and hyponatremia.

In the case of the appointment of Nourem to the elderly, it is necessary to monitor the concentration of sodium in the plasma before therapy, 3 days after the start of the course and with each increase in the dose.

Drug interactions

• non-steroidal anti-inflammatory drugs (indomethacin), clofibrate, selective serotonin reuptake inhibitors, tricyclic antidepressants, chlorpropamide, chlorpromazine, carbamazepine and other drugs that can lead to the development of a syndrome of inadequate ADH production delay: they can increase the antidiuretic effect and the appearance of the threat of the antidiuretic effect; when combining desmopressin with these agents, careful monitoring of blood pressure, sodium content in the blood and urine volume is necessary;
• glibenclamide, lithium preparations: a decrease in the antidiuretic activity of desmopressin is possible;
• hypertensive drugs: the effect of these drugs is enhanced;
• oxytocin: antidiuretic effect increases and uterine perfusion decreases;
• loperamide: there is a possibility of a threefold increase in the plasma concentration of desmopressin, a significant aggravation of the risk of fluid retention and the appearance of hyponatremia; other drugs that weaken the tone and motility of intestinal smooth muscles may also have a similar effect;
• drugs metabolized in the liver: interaction is unlikely, since desmopressin does not significantly affect hepatic metabolism;
• indomethacin: enhances the effect of desmopressin, but does not increase the duration of the effect.

Analogs

Nourem's analogs are Adiupresin, Adiuretin SD, Apo-Desmopressin, Desmopressin, Vazomirin, Antiqua Rapid, Minirin, Nativa, Minirin Melt, etc.

Terms and conditions of storage

Store in a place protected from moisture and light, out of reach of children, at a temperature not exceeding 25 ° C.

Shelf life is 2 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Nourem

At the moment, there are no reviews on Nourem left by patients or specialists on specialized sites, on the basis of which it would be possible to objectively assess its effectiveness and disadvantages.

Price for Nourem in pharmacies

The price of Nourem depends on the dosage and can be for a package containing 30 pieces: 0.1 mg tablets - 1100-1450 rubles, 0.2 mg tablets - 2000-2300 rubles.

Knowrem: prices in online pharmacies

Drug name Price Pharmacy

Nourem 0.1 mg tablets 30 pcs. 1269 RUB Buy

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!