Raunatine (Tablets) Instructions for Use

ATC Code

C02AA04 (Total rauwolfia alkaloids)

Active Substance

Rauwolfia serpentina (USP United States Pharmacopeia)

Clinical-Pharmacological Group

Sympatholytic. Antihypertensive drug

Pharmacotherapeutic Group

Antihypertensive agent of plant origin

Pharmacological Action

Rauwolfia alkaloids have hypotensive and antiarrhythmic action.

The sedative effect is less pronounced than that of reserpine, but in terms of hypotensive action they are practically not inferior to reserpine, while in a number of cases they are better tolerated.

The hypotensive effect develops more slowly than that of reserpine.

Indications

This preparation is indicated for the management of mild to moderate arterial hypertension.

It is used as part of a comprehensive treatment plan to achieve and maintain blood pressure control.

Initiate therapy only after a thorough evaluation by a healthcare professional to confirm the diagnosis and determine the appropriateness of this treatment.

ICD codes

Dosage Regimen

Administer orally, after meals to improve tolerability. Initiate therapy according to a specific dosing scheme, which involves a gradual increase in the dose to minimize adverse effects.

After achieving the desired therapeutic effect, typically observed after 10 to 14 days of treatment, begin to gradually reduce the dose to the lowest effective level that maintains blood pressure control, known as the maintenance dose.

Adhere strictly to the prescribed regimen and do not discontinue abruptly. The dosage must be individualized based on the patient’s response and tolerance.

Adverse Reactions

Patients may experience swelling of the nasal mucosa, which can lead to congestion, as well as increased sweating and generalized asthenia or weakness.

Cardiovascular effects can include bradycardia and cardialgia. Neuropsychiatric adverse reactions such as depression and a decreased libido have been reported.

Monitor for these and other potential reactions, as their severity can vary. Report any persistent or severe symptoms to a healthcare provider promptly.

Contraindications

• Arterial hypotension and known hypersensitivity to rauwolfia alkaloids.
• Established or suspected depression due to the risk of exacerbation.
• Significant cardiac conditions including insufficiency of coronary circulation, organic myocardial lesions, and aortic defects.
• Active peptic ulcer of the stomach and duodenum and the presence of nephrosclerosis.
• The third trimester of pregnancy and use in children and adolescents under 18 years of age.

Drug Interactions

Exercise caution when co-administering with quinidine, guanethidine, cardiac glycosides, and beta-blockers due to a potential increase in the severity of negative chronotropic and dromotropic effects.

Concomitant use with other antihypertensive agents, such as ganglioblockers, hydrochlorothiazide, or hydralazine, may lead to an additive hypotensive effect, requiring careful dose titration and monitoring of blood pressure.

Inform your healthcare provider about all concomitant medications, including prescription, over-the-counter, and herbal products.

Contraindications

• Arterial hypotension and known hypersensitivity to rauwolfia alkaloids.
• Established or suspected depression due to the risk of exacerbation.
• Significant cardiac conditions including insufficiency of coronary circulation, organic myocardial lesions, and aortic defects.
• Active peptic ulcer of the stomach and duodenum and the presence of nephrosclerosis.
• The third trimester of pregnancy and use in children and adolescents under 18 years of age.

Overdose

Symptoms of overdose are primarily an exaggeration of known pharmacological effects, including severe hypotension leading to shock, profound bradycardia, excessive sedation, and hypothermia.

Management is supportive and symptomatic. There is no specific antidote. Institute measures to support circulation and respiration. Gastric lavage may be considered if ingestion was recent.

Immediately discontinue the drug and seek urgent medical attention or contact a poison control center. Treatment should be directed at correcting hypotension and managing cardiac arrhythmias.

Use in Pregnancy and Lactation

Contraindicated during pregnancy (third trimester), during lactation.

Pediatric Use

Contraindicated in children and adolescents under 18 years of age.

Special Precautions

Simultaneous or sequential use with other antihypertensive agents (ganglioblockers, hydrochlorothiazide, hydralazine) is possible.

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.