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Hypothiazid®

Non-melanoma skin cancer, lip cancer

Two epidemiological studies based on the Danish National Cancer Registries showed an increased risk of developing non-melanoma skin cancer and lip cancer (basal cell carcinoma of the skin and squamous cell carcinoma of the skin) with increasing cumulative dose of hydrochlorothiazide.

Hydrochlorothiazide has a photosensitizing effect, which may cause the development of non-melanoma skin and lip cancer.

Patients taking hydrochlorothiazide should be informed of the risk of developing non-melanoma skin and lip cancer and the need to regularly examine the skin for new changes as well as changes in existing ones. If any suspicious skin lesions are detected, the patient should immediately consult a doctor.

Particular attention should be paid to patients who have known risk factors for skin cancer, including: skin phototypes I and II (pale and fair skin), a family history of skin cancer, a history of skin damage caused by solar or ultraviolet radiation and radiation therapy, smoking and taking drugs with photosensitizing effects.

Patients should be advised to take measures to prevent the development of skin cancer, such as limiting time in the sun and exposure to ultraviolet rays, and using appropriate sunscreens when exposed to the sun.

Any suspicious skin lesions should be immediately examined, including histological examination of material obtained by biopsy of tissue at the site of the lesion. It may also be necessary to reconsider the use of hydrochlorothiazide in patients with a history of non-melanoma skin cancer and lip cancer.

Renal dysfunction

In patients with impaired renal function, hydrochlorothiazide may cause azothermia. In case of renal failure, accumulation of hydrochlorothiazide is possible.

In patients with reduced renal function, periodic monitoring of creatine clearance is necessary. If renal dysfunction progresses and/or oliguria (anuria) occurs, hydrochlorothiazide should be discontinued.

Liver dysfunction

When using thiazide diuretics in patients with impaired liver function, hepatic encephalopathy may develop. In patients with severe liver failure or hepatic encephalopathy, the use of thiazides is contraindicated.

In patients with mild to moderate hepatic impairment and/or progressive liver disease, hydrochlorothiazide should be used with caution, since even slight changes in fluid and electrolyte balance and serum ammonium accumulation can cause hepatic coma. If symptoms of encephalopathy occur, diuretics should be discontinued immediately.

Water-electrolyte balance and metabolic disorders

Thiazide diuretics (including hydrochlorothiazide) can cause a decrease in the volume of circulating fluid (hypovolemia) and disturbances in water and electrolyte balance (including hypokalemia, hyponatremia, hypochloremic alkalosis).

Clinical symptoms of water and electrolyte imbalance are dry mouth, thirst, weakness, lethargy, fatigue, drowsiness, anxiety, muscle pain or cramps, muscle weakness, marked decrease in blood pressure, oliguria, tachycardia, arrhythmia and gastrointestinal disorders ( such as nausea and vomiting).

In patients receiving hydrochlorothiazide therapy (especially with long-term course treatment), clinical symptoms of water-electrolyte imbalance should be identified and blood electrolyte levels should be regularly monitored.

Sodium

All diuretics can cause hyponatremia, sometimes leading to severe complications. Hyponatremia and hypovolemia can lead to dehydration and orthostatic hypotension. A concomitant decrease in chlorine ions can lead to secondary compensatory metabolic alkalosis, but the frequency and severity of this effect are insignificant. It is recommended to determine the content of sodium ions in the blood plasma before starting treatment and regularly monitor this indicator while taking hydrochlorothiazide.

Potassium

When using thiazide and thiazide-like diuretics, there is a risk of a sharp decrease in the potassium content in the blood plasma and the development of hypokalemia (potassium concentration less than 3.4 mmol/l).

Hypokalemia increases the risk of developing heart rhythm disturbances (including severe arrhythmias) and enhances the toxic effect of cardiac glycosides. In addition, hypokalemia (as well as bradycardia) is a condition that contributes to the development of polymorphic ventricular tachycardia of the “pirouette” type, which can be fatal.

Hypokalemia poses the greatest danger to the following groups of patients: elderly people, patients simultaneously receiving therapy with antiarrhythmic and non-antiarrhythmic drugs that can cause polymorphic ventricular tachycardia of the "pirouette" type or increase the duration of the QT interval on the ECG, patients with impaired liver function, coronary heart disease , chronic heart failure.

In addition, patients with an increased QT interval are at increased risk. It does not matter whether this increase in the interval is caused by congenital causes or the effect of drugs.

In all the cases described above, it is necessary to avoid the risk of developing hypokalemia and regularly monitor the potassium content in the blood plasma. The first measurement of the content of potassium ions in the blood must be carried out within the first week from the start of treatment. If hypokalemia occurs, appropriate treatment should be prescribed.

Hypokalemia can be corrected by using potassium-containing medications or eating foods rich in potassium (dried fruits, fruits, vegetables).

Calcium

Thiazide diuretics may reduce the excretion of calcium ions by the kidneys, leading to a slight and temporary increase in plasma calcium levels. In some patients, with long-term use of thiazide diuretics, pathological changes in the parathyroid glands with hypercalcemia and hyperphosphatemia were observed, but without the typical complications of hyperparathyroidism (nephrolithiasis, decreased bone mineral density, peptic ulcer).

Severe hypercalcemia may be a manifestation of previously undiagnosed hyperparathyroidism.

Because of their effect on calcium metabolism, thiazides may interfere with laboratory parameters of parathyroid function. Thiazide diuretics (including hydrochlorothiazide) should be discontinued before testing parathyroid function.

Magnesium

Thiazides have been found to increase renal excretion of magnesium, which can lead to hypomagnesemia. The clinical significance of hypomagnesemia remains unclear.

Glucose

Treatment with thiazide diuretics may impair glucose tolerance. When using hydrochlorothiazide in patients with manifest or latent diabetes mellitus, it is necessary to regularly monitor the concentration of glucose in the blood. Dosage adjustments of hypoglycemic medications may be necessary.

Uric acid

In patients with gout, the frequency of attacks may increase or the course of gout may worsen. Careful monitoring of patients with gout and impaired uric acid metabolism (hyperuricemia) is necessary.

Lipids

When using hydrochlorothiazide, the concentration of cholesterol and triglycerides in the blood plasma may increase.

Acute myopia/secondary angle-closure glaucoma

Hydrochlorothiazide can cause an idiosyncratic reaction, leading to the development of acute myopia and an acute attack of secondary angle-closure glaucoma. Symptoms include: sudden loss of visual acuity or eye pain, usually occurring within hours to weeks of starting hydrochlorothiazide therapy. If left untreated, acute angle-closure glaucoma can lead to irreversible vision loss. If symptoms occur, you should stop taking hydrochlorothiazide as soon as possible. If intraocular pressure remains uncontrolled, emergency medical treatment or surgery may be required.

Risk factors for the development of acute angle-closure glaucoma are: a history of an allergic reaction to sulfonamides or penicillin.

Immune system disorders

There are reports that thiazide diuretics (including hydrochlorothiazide) may cause exacerbation or progression of systemic lupus erythematosus, as well as lupus-like reactions.

In patients receiving thiazide diuretics, hypersensitivity reactions may occur even in the absence of a history of allergic reactions or bronchial asthma.

Photosensitivity

Cases of photosensitivity reactions have been reported when taking thiazide diuretics. If photosensitivity occurs while taking hydrochlorothiazide, treatment should be discontinued.

Ethanol (alcohol)

During treatment with hydrochlorothiazide, it is not recommended to drink alcoholic beverages, because ethanol enhances the antihypertensive effect of thiazide diuretics.

Other

In patients with severe atherosclerosis of the cerebral and coronary arteries, hydrochlorothiazide should be used with extreme caution.

Thiazide diuretics can reduce the amount of iodine bound to plasma proteins without causing signs of thyroid dysfunction.

Thiioside tablets 8 mg No. 20

Compound

active ingredient:
thiocolchicoside;

1 tablet contains thiocolchicoside 8 mg

Excipients

: copolyvidone, lactose, corn starch, microcrystalline cellulose, colloidal silicon dioxide, sodium stearyl fumarate.

Dosage form

Pills.

Basic physical and chemical properties:

Round, biconvex, yellow tablets with a break line on one side and an “8” engraved on the other side.

Pharmacotherapeutic group

Centrally acting muscle relaxants. ATX code M03B X05.

Pharmacodynamics

Thiocolchicoside is a semi-synthetic muscle relaxant that is obtained from the glycoside colchicoside. Shows selective affinity for gamma-aminobutyric acid (GABA) and the glycine receptor.

The muscle relaxant effect manifests itself predominantly at the supraspinal level, due to complex regulatory mechanisms; a glycinergic mechanism of action is also possible.

The binding of thiocolchicoside to GABA is qualitatively and quantitatively shared with its active metabolite, a glucuronidated derivative.

Thiocolchicoside and its derivatives do not have a sedative effect.

Pharmacokinetics

Suction

After a single dose of 8 mg of thiocolchicoside, the maximum concentration (max) is reached within 30 minutes and reaches a value of 175 ng/ml. The area under the concentration-time curve (AUC) is 417 ng/mL.

The pharmacologically active metabolite SL18.0740 also appears at lower concentrations with a Cmax of 11.7 ng/mL, achieved 5 hours after dosing, and an AUC of 83 ng/mL. There are no available data on the inactive metabolite SL59.0955.

After oral administration of thiocolchicoside, only two metabolites are detected in the blood plasma: the pharmacologically active metabolite SL18.0740 and the inactive metabolite SL59.0955. The maximum plasma concentration of both thiocolchicoside metabolites is achieved after 60 minutes. After a single dose of 8 mg, the Cmax and AUC values of the SL18.0740 metabolite are approximately 60 ng/ml and 130 ng/ml, respectively. In the metabolite SL59.0955, the value is much lower: Cmax is about 13 ng/ml, and AUC ranges from 15.5 ng/ml (up to 3 hours) to 39.7 ng/ml (up to 24 hours) .

Distribution

The volume of distribution of thiocolchicoside is approximately 42.7 L after administration of 8 mg. There are no data on the volume of distribution of metabolites.

Metabolism

After oral administration, thiocolchicoside is rapidly metabolized to aglycone-3-dimethylthiocolchicoside or SL59.0955. This, mainly due to intestinal metabolism, explains the absence of unchanged thiocolchicoside after oral administration. The metabolite SL59.0955 glucuronidizes to SL18.0740 which has equivalent pharmacological activity to thiocolchicoside and thus provides pharmacological activity after oral administration of thiocolchicoside. SL59.0955 is also demethylated to dimethylthiocolchicine.

Conclusion

After oral administration, 14C-thiocolchicoside is mainly excreted in feces (79%), and only 20% in urine. Unchanged thiocolchicoside is excreted in urine or feces. Metabolites SL18.0740 and SL59.0955 are found in urine and feces, while didemethylthiocolchicine is excreted only in feces.

After oral administration of thiocolchicoside, the half-life of the SL18.0740 metabolite is 3.2-7 hours and the SL59.0955 metabolite averages 0.8 hours.

Indications

Symptomatic treatment of painful muscle contractures in spinal cord pathologies.

Contraindications

Hypersensitivity to the active substance or other components of the drug
During pregnancy and breastfeeding
use in women of childbearing age who do not use contraception.

Interaction with other drugs and other types of interactions

There are no data on drug interactions. However, caution is recommended when used concomitantly with other muscle relaxants.

When used simultaneously with drugs that depress the central nervous system, including alcohol, antihypertensive drugs, and curare-like drugs, increased muscle relaxation and depression of the central nervous system and the development of hypotension are possible.

When used simultaneously with anticoagulants, the risk of bleeding increases.

Features of application

Thiocolchicoside is not recommended for use in children under 16 years of age.

If nausea occurs, the dose of the drug should be reduced.

Thiocolchicoside may cause seizures in patients with a history of seizures or epilepsy.

One of the metabolites of thiocolchicoside (SL59.0955) is known to induce aneuploidy (that is, an unequal number of chromosomes in dividing cells) at concentrations close to those detected in human plasma when administered at a dose of 8 mg 2 times a day orally. Aneuploidy is a risk factor for teratogenicity, embryo-/fetotoxicity, spontaneous miscarriage, impaired male fertility, and the development of cancer. Therefore, you should avoid using the drug in doses higher than recommended and for a long time.

Women of childbearing age should be informed of the potential risks during pregnancy and the need to use effective contraception.

The drug contains lactose, therefore patients with rare hereditary forms of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption syndrome should not use the drug.

The ability to influence reaction speed when driving a vehicle or operating machinery

During the treatment period, care must be taken when driving vehicles or engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions, due to the possibility of drowsiness.