ACTION AND MECHANISM

Combination of an orexigenic (appetite stimulant) and amino acids. The appetite-stimulating effect is primarily due to the antiserotonergic action of cyproheptadine, which antagonizes serotonin 5-HT2 (S2) receptors. It also has antihistamine H1 and anticholinergic (M) effects.

SENIORS

In elderly patients receiving antihistamines, dizziness, sedation, confusion, and hypotension are more likely to occur, and a paradoxical reaction characterized by hyperexcitability may also occur. Geriatric patients are more sensitive to the anticholinergic side effects of antihistamines, such as dry mouth and urinary retention. If these effects persist or are severe, the medication should probably be discontinued.

CONTRAINDICATIONS

- Allergy to cyproheptadine or other components of the formula.- [ASTHMA ATTACK].- Pregnancy, breastfeeding and children under 2 years of age.- Malignant [CANCER] (may promote its development).

DOPING

This medication contains alcohol. Its use is prohibited during competition in certain sports. Detection will be performed by breath and/or blood analysis. The threshold for an anti-doping rule violation (hematological level) is 0.1 g/l in the following sports: aeronautics, motorsports, motorcycling, motorboating, and archery.

Alcohol is considered a specific substance, and therefore, a violation of a rule involving this substance may result in a reduced penalty provided the athlete can demonstrate that the use of the specific substance in question was not intended to enhance athletic performance.

PREGNANCY

FDA Category B. Studies in rats have not shown teratogenic effects. There are no adequate or well-controlled studies in humans. However, there have been isolated cases of children with cleft lip and hypospadias using cyproheptadine during the first trimester, although a causal relationship cannot be established. Cyproheptadine has been used to prevent spontaneous abortion in patients with elevated serotonin production and in the treatment of Cushing's syndrome, with no observed congenital problems. This drug is only approved for use in the absence of safer therapeutic alternatives.

INDICATIONS

- [ANOREXIA], [ASTHENIA].- [CONVALESCENCE], fatigue.

INTERACTIONS

- Alcohol: Studies with other antihistamines (chlorpheniramine, diphenhydramine, promethazine) have reported alterations in motor and/or mental function due to the possible addition of their central depressant effects.- Antidepressants (fluoxetine, phenelzine, paroxetine): Studies have reported inhibition of the antidepressant effect. The mechanism has not been established, although it is suggested that cyproheptadine may antagonize the serotonergic effects of antidepressants.

LACTATION

It is not known whether this medication is excreted in significant amounts in breast milk, and whether this could affect the infant. It is recommended to discontinue breastfeeding or avoid administration of this medication.

CHILDREN

The safety and efficacy of cyproheptadine have not been established in children younger than 2 years. Its use is not recommended in premature infants or newborns because they are more sensitive to the anticholinergic side effects of antihistamines, such as CNS excitation. A paradoxical reaction characterized by hyperexcitability may occur in older children receiving antihistamines.

RULES FOR CORRECT ADMINISTRATION

Take 1 hour before meals.

POSOLOGY

Adults: 1 spoonful (10 ml) 3 times a day. Children: 2 to 6 years: 1 spoonful (5 ml) 1-2 times a day. 6 to 14 years: 1 spoonful (10 ml) 2 times a day.

PRECAUTIONS

- Due to its anticholinergic effects, special clinical monitoring should be carried out in patients with chronic [EPILEPSY], [ASTHMA], [CHRONIC OBSTRUCTIVE PULMONARY DISEASE], [GLAUCOMA], [INTESTINAL OBSTRUCTION] or [OBSTRUCTIVE UROPATHY], [URINARY RETENTION], [PROSTATIC HYPERPLASIA], [HYPERTHYROIDISM], [ARTERIAL HYPERTENSION]. - Driving vehicles or operating dangerous or precision machinery under its influence is not advisable (it may reduce the ability to concentrate and reflexes). - The elderly and debilitated patients are more sensitive to the anticholinergic effects (greater predisposition to experience sedation, dizziness and hypotension).

PRECAUTIONS RELATED TO EXCIPIENTS

- This medicine contains ethanol. It is recommended to check the composition for the exact amount of ethanol per dose.

* Amounts less than 100 mg/dose are considered small and are not usually harmful, especially in children.

* Amounts greater than 100 mg/dose may be harmful to people with [CHRONIC ALCOHOLISM], and should also be taken into account in pregnant and lactating women, children, and in high-risk groups, such as patients with [LIVER DISEASE] or [EPILEPSY].

* Amounts greater than 3 g/dose may impair the ability to drive or operate machinery, and may interfere with the effects of other medications.

ADVERSE REACTIONS

The adverse effects of cyproheptadine are generally mild and transient. The most common adverse reactions are: - Occasionally (1-9%): drowsiness, dry mouth, blurred vision. - Rarely (<1%): constipation, mydriasis, accommodation disorders, mental confusion in the elderly, excitation and insomnia in young children, urinary retention, palpitations, hypotension, headache, rash, urticaria, photodermatitis.

COMPOSITION

CARNITINE: 62.5 MILLIGRAMS - HYDROCHLORIDE
CYPROHEPTADINE: 0.5 MILLIGRAMS - HYDROCHLORIDE
LYSINE: 1.25 MILLIGRAMS - HYDROCHLORIDE
ETHYL ALCOHOL (EXCIPIENT): 48.9 MILLIGRAMS
SUCROSE (EXCIPIENT): 300 MILLIGRAMS
PROPYL PARAHYDROXYBENZOATE (E-216) (EXC: 0.1 MILLIGRAMS - SODIUM (SALT)
AMARANTH (E-123) (EXCIPIENT): 8.25 MICROGRAMS