Reladorm - Instructions For Use, Indications, Doses, Analogues

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

Reladorm

Instructions for use:

1. 1. Release form and composition
2. 2. Indications for use
3. 3. Contraindications
4. 4. Method of application and dosage
5. 5. Side effects
6. 6. Special instructions
7. 7. Drug interactions
8. 8. Analogs
9. 9. Terms and conditions of storage
10. 10. Terms of dispensing from pharmacies

Reladorm is a combined drug with sedative, hypnotic and anxiolytic effects.

Release form and composition

The dosage form of Reladorm is tablets: flat-cylindrical, round, white or grayish-white, beveled on both sides, on one side there is a risk (10 pcs. In blisters and bezelzheykovyh packaging, 1 package in a cardboard box).

Active ingredients in 1 tablet:

• Diazepam - 10 mg;
• Cyclobarbital Calcium 100 mg

Additional components: sodium carboxymethyl starch, potato starch, gelatin, talc, lactose monohydrate.

Indications for use

Reladorm is prescribed for the symptomatic treatment of sleep disorders of various origins.

Contraindications

Absolute:

• Respiratory failure in severe course (regardless of the cause);
• Sleep apnea syndrome;
• Hereditary lactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption;
• Renal / hepatic impairment in severe course;
• Glaucoma;
• Myasthenia gravis (myasthenia gravis);
• Acute porphyria;
• Poisoning with alcohol or drugs with a depressing effect on the central nervous system;
• Children and elderly (over 65) age;
• Pregnancy and lactation;
• Hypersensitivity to the components of the drug, as well as to derivatives of 1,4-benzodiazepine and barbituric acid.

Relative (Reladorm should be taken with caution in the presence of the following diseases / conditions):

• Renal / hepatic impairment of moderate or mild severity;
• Chronic respiratory failure;
• Mild forms of porphyria;
• Depression;
• History of suicidal thoughts and attempts;
• History of drug, alcohol or drug addiction.

It is not recommended to use Reladorm for patients with psychosis.

During the period of therapy, as well as for 3 days after the end of the course, you should not drink alcohol.

Method of administration and dosage

Reladorm is taken orally with a small amount of water. It is not recommended to take the drug for more than 7 days.

It is necessary to strictly adhere to the dosage regimen prescribed by the doctor.

As a rule, for adults, Reladorm is prescribed ½ or 1 tablet one hour before bedtime.

For mild to moderate renal / hepatic impairment, take the lowest recommended dose (½ tablet).

Taking Reladorm for longer than the prescribed period (for example, over several weeks) can cause drug dependence. In this case, it is impossible to abruptly interrupt therapy because of the likelihood of the development of withdrawal symptoms in the form of sleep and mood disorders, impaired attention and concentration, increased irritability (a gradual dose reduction controlled by a doctor is required).

If you miss a single dose, you need to take it as soon as possible or skip it. Do not double the dose.

Side effects

The severity and frequency of adverse reactions depend on the individual sensitivity of the patient and the dose of Reladorm.

The most common side effects include: ataxia, dizziness, headache, drowsiness, retardation of psychomotor functions, disorientation, confusion.

In more rare cases, there is the development of disorders such as general weakness, a feeling of dry mouth, fainting, visual disturbances (in the form of blurred vision, diplopia), dysarthria (in the form of slurred speech and incorrect pronunciation), liver dysfunction, memory impairment, gastrointestinal - intestinal disorders, muscle tremors, libido disorders, menstrual irregularities, changes in the morphological composition of the blood (agranulocytosis, leukopenia), a slight decrease in blood pressure, urinary incontinence, allergic skin reactions, paradoxical reactions (in the form of psychomotor agitation, insomnia, increased excitability and aggressiveness, muscle tremors, seizures; most often develop with alcohol consumption, in elderly patients and in patients with mental illness).

The reasons for discontinuation of therapy are: increased activity of liver enzymes, anuria, visual impairment, dysfunction of the hematopoietic system, jaundice.

The systematic use of Reladorm longer than the period recommended in the instructions can lead to the development of drug dependence, abrupt cancellation of therapy - to the emergence of withdrawal symptoms.

special instructions

Before prescribing Reladorm, you need to carefully analyze the existing disorders, excluding other possible causes of insomnia (psychogenic, somatogenic, bad habits).

During therapy, patients should be closely monitored.

The risk of developing drug dependence is dose-dependent. The likelihood of this disorder increases in patients with anamnestic data on the presence of dependence on other drugs, in patients with alcohol dependence, as well as with prolonged use of the drug. The potential for drug dependence increases when combined with cyclobarbital.

Abrupt cessation of therapy against the background of drug dependence can lead to the development of withdrawal symptoms (characteristic symptoms: headache and muscle pain, emotional stress, psychomotor agitation, disorientation, insomnia, motor restlessness, confusion, increased irritability). In severe cases, there may be: loss of a sense of the reality of the environment, personality disorders, increased sensitivity to touch, visual and auditory stimuli, numbness of the extremities, a feeling of "creeping", seizures, hallucinations.

Reladorm can lead to the development of antegrade amnesia (in most cases several hours after administration, especially after taking a large dose of the drug). It is recommended to provide conditions for continuous 7-8 hours of sleep, and also take Reladorm 60 minutes before bedtime.

When symptoms of paradoxical reactions appear, therapy is canceled.

Due to the likelihood of developing suicidal thoughts, the drug should be administered with caution to patients with symptoms of endogenous depression (the recommended daily dose is ½ tablet). Also, caution is required by the use of Reladorm in patients prone to suicidal actions (worsening of the condition is possible), with a mild form of porphyria (possibly increased symptoms).

Periodically during therapy, it is necessary to conduct studies of the morphological composition of peripheral blood, as well as functional tests of the liver.

It is impossible to drive vehicles and perform other potentially dangerous work, which requires increased concentration of attention and quick psychomotor reactions, while taking Reladorm, and also for 3 days after its cancellation.

Drug interactions

With the combined use of Reladorm with certain drugs / substances, the following effects may be observed:

• Sedatives, hypnotics, antihistamines, antidepressants, narcotic analgesics, monoamine oxidase inhibitors, drugs for general anesthesia (anesthetics), antihypertensive drugs of central action: increasing the inhibitory effect of Reladorm on the central nervous system;
• Narcotic analgesics: the development of severe euphoria (can lead to a more rapid development of drug dependence);
• Alcohol: an increase in its depressing effect on the central nervous system, the development of paradoxical reactions (in the form of psychomotor agitation, aggressive behavior, pathological intoxication or the appearance of symptoms of deep depression of brain function);
• Indirect anticoagulants - derivatives of coumarin, doxycycline, hypoglycemic drugs, griseofulvin: a decrease in their effectiveness;
• Levodopa: weakening of its action;
• Phenytoin, drugs that reduce skeletal muscle tone: enhancing their action;
• Cimetidine, disulfiram, antifungal agents (for example, ketoconazole), some antibacterial drugs (for example, erythromycin), antiviral drugs (for example, ritonavir): enhancement of the pharmacological action of Reladorm;
• Oral contraceptives: decrease in their effectiveness;
• Rifampicin, theophylline and tobacco smoking: accelerating the metabolism of diazepam and weakening its pharmacological action;
• Digoxin, glucocorticosteroids, cyclosporine, theophylline: increasing their metabolism;
• Slow calcium channel blockers, alpha-blockers, angiotensin-converting enzyme inhibitors, angiotensin II receptor antagonists: increasing blood pressure lowering.

Analogs

There is no information about Reladorm analogues.

Terms and conditions of storage

Store in a dark, dry place out of reach of children at temperatures up to 25 ° C.

The shelf life is 3 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!