Valosemide (Drops) Instructions for Use

Marketing Authorization Holder

Usolye-Sibirskiy Chemical and Pharmaceutical Plant, JSC (Russia)

ATC Code

N05CM (Other hypnotic and sedative drugs)

Active Substances

Phenobarbital (Rec.INN WHO registered)

Ethylbromisovalerinate (Grouping name)

Dosage Form

Valosemide

Oral drops 20 mg/ml+20 mg/ml: 15 ml or 25 ml bottle or dropper bottles

Dosage Form, Packaging, and Composition

Oral drops as a transparent, colorless liquid with a characteristic odor.

Excipients: peppermint oil – 1.4 mg, oregano oil – 0.2 mg, ethanol (ethyl alcohol) 95% – 520 mg, purified water – up to 1 mg.

15 ml – bottles – cardboard packs.
15 ml – bottles (50) – cardboard boxes (for hospitals).
15 ml – bottles (60) – cardboard boxes (for hospitals).
15 ml – bottles (80) – cardboard boxes (for hospitals).
15 ml – bottles (100) – cardboard boxes (for hospitals).
15 ml – bottles (140) – cardboard boxes (for hospitals).
15 ml – bottles (150) – cardboard boxes (for hospitals).
15 ml – bottles (200) – cardboard boxes (for hospitals).
15 ml – dropper bottles – cardboard packs.
15 ml – dropper bottles (50) – cardboard boxes (for hospitals).
15 ml – dropper bottles (60) – cardboard boxes (for hospitals).
15 ml – dropper bottles (80) – cardboard boxes (for hospitals).
15 ml – dropper bottles (100) – cardboard boxes (for hospitals).
15 ml – dropper bottles (140) – cardboard boxes (for hospitals).
15 ml – dropper bottles (150) – cardboard boxes (for hospitals).
15 ml – dropper bottles (200) – cardboard boxes (for hospitals).
25 ml – bottles – cardboard packs.
25 ml – bottles (50) – cardboard boxes (for hospitals).
25 ml – bottles (60) – cardboard boxes (for hospitals).
25 ml – bottles (80) – cardboard boxes (for hospitals).
25 ml – bottles (100) – cardboard boxes (for hospitals).
25 ml – bottles (140) – cardboard boxes (for hospitals).
25 ml – bottles (150) – cardboard boxes (for hospitals).
25 ml – bottles (200) – cardboard boxes (for hospitals).
25 ml – dropper bottles – cardboard packs.
25 ml – dropper bottles (50) – cardboard boxes (for hospitals).
25 ml – dropper bottles (60) – cardboard boxes (for hospitals).
25 ml – dropper bottles (80) – cardboard boxes (for hospitals).
25 ml – dropper bottles (100) – cardboard boxes (for hospitals).
25 ml – dropper bottles (140) – cardboard boxes (for hospitals).
25 ml – dropper bottles (150) – cardboard boxes (for hospitals).
25 ml – dropper bottles (200) – cardboard boxes (for hospitals).

Clinical-Pharmacological Group

Sedative agent

Pharmacotherapeutic Group

Sedative

Pharmacological Action

A combined drug, the action of which is determined by the properties of its constituent substances. It has a sedative and antispasmodic effect. It facilitates the onset of natural sleep.

Phenobarbital has a vasodilating, hypnotic (in appropriate doses) and mild hypotensive effect, and enhances the sedative effect of other components.

Ethylbromisovalerinate (ethyl ester of α-bromoisovaleric acid) has a sedative (similar to the effect of valerian) and antispasmodic effect.

Peppermint oil, included in some combined drugs as an auxiliary component, has a reflex vasodilating and antispasmodic effect. Some drugs include hop cone oil or oregano oil as auxiliary components.

Indications

As a sedative and vasodilator for insomnia (difficulty falling asleep); cardialgia; sinus tachycardia; neurotic conditions; autonomic lability; irritability; hypochondriacal syndrome; arterial hypertension (early stages).

As an antispasmodic agent for spasms of the gastrointestinal tract muscles (intestinal and biliary colic).

ICD codes

Dosage Regimen

Administer orally, before meals. Dilute the required number of drops in 30-50 ml of water immediately prior to ingestion.

For adults, prescribe 15-30 drops two to three times daily. For specific indications such as tachycardia, increase the single dose to 40-50 drops.

For pediatric patients, administer 3-15 drops per day. Adjust the exact daily dose based on the child’s age and the clinical presentation of the condition.

Determine the duration of therapy individually, based on therapeutic response and tolerability. Limit long-term use to minimize the risk of adverse effects such as drug dependence or chronic bromine intoxication.

Monitor patients for signs of excessive sedation, dizziness, or allergic reactions. Exercise caution in patients with a history of substance abuse or those operating vehicles or machinery.

Avoid concurrent use with alcohol, other central nervous system depressants, and medications whose metabolism is induced by phenobarbital, due to potential for significant interactions.

Adverse Reactions

Possible drowsiness, dizziness, decreased ability to concentrate, allergic reactions.

With long-term use development of chronic bromine poisoning (depression, apathy, rhinitis, conjunctivitis, hemorrhagic diathesis, impaired coordination of movements); drug dependence.

Contraindications

Severe hepatic and/or renal impairment; lactation period; hypersensitivity to the components of the drug.

With caution pregnancy.

Use in Pregnancy and Lactation

Should be used with caution during pregnancy.

If it is necessary to use during lactation, the issue of discontinuing breastfeeding should be decided.

Use in Hepatic Impairment

Contraindicated in severe hepatic impairment.

Use in Renal Impairment

Contraindicated in severe renal impairment.

Pediatric Use

The drug is approved for use in children and adolescents under 18 years of age.

Special Precautions

Effect on the ability to drive vehicles and mechanisms

During the treatment period, caution should be exercised when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Drug Interactions

Sedatives – enhancement of the effect.

Methotrexate – possible increase in methotrexate toxicity.

Neuroleptics and anxiolytics – possible enhancement of the drug’s action.

CNS stimulants – weakening of the action of each of the drug’s components.

Ethanol – enhancement of the drug’s effects and increase in its toxicity.

Antibiotics, sulfonamides – reduction of antibacterial activity due to the presence of phenobarbital in the drug composition.

Griseofulvin – reduction in the degree of absorption and, as a consequence, weakening of the antifungal action (due to the presence of phenobarbital in the drug composition).

Indirect anticoagulants, corticosteroids, doxycycline, estrogens and other drugs metabolized in the liver via oxidation – reduction in effectiveness, because Phenobarbital accelerates their destruction.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.