International non-patented name: Cyproheptadine + Vitamin B group

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Composition

Active ingredients: 2 mg of anhydrous cyproheptadine hydrochloride in 5 ml of syrup,

1.2 mg vitamin B1 (thiamine hydrochloride), 1.2 mg vitamin B2 (riboflavin),

Contains 1.2 mg of nicotinamide, 1.2 mg of vitamin B6 (pyridoxine hydrochloride).

Excipients: thiosidic acid, sodium methylhydroxybenzoate, sodium propylhydroxybenzoate,

sodium hydroxide, sucralose, propylene glycol, glycerin, xanthan gum, disodium

edetate, hydrochloric acid, sodium chloride, mango (flavor), purified water.

 

Description

It is a yellow transparent solution.

 

Pharmacotherapeutic group

Medicine to stimulate appetite and harmonious development.

ATC code:A15.

 

pharmacological properties

Due to the pharmacological properties of its components, Trimetavit syrup is a medicine that increases appetite, improves digestion, absorption and assimilation of food, increases body weight, and ensures harmonious physical development of the body in poorly developing, anorexic, weakened and recovering patients.

Cyproheptadine, the main active substance of the drug, is an antagonist of serotonin and histamine receptors. At the level of the hypothalamus (the part of the brain responsible for appetite regulation) it stimulates the appetite. Cyproheptadine improves weight and height growth.

Group B vitamins (B1, B2, B3 and B6) participate as coenzymes in the metabolism of lipids, proteins and carbohydrates, ensuring optimal functioning of enzyme systems and complete absorption of absorbed food at the cellular level.

Pharmacokinetics

Cyproheptadine

It is well absorbed after oral administration. It reaches the maximum concentration in plasma in 6-9 hours. It undergoes significant metabolism in the liver. Its metabolism consists of demethylation with subsequent oxidation and hydroxylation with subsequent sulfoconjugation. Renal clearance is 2/3-3/4 of the total clearance. It is excreted from the body through the intestines (2-20%, of which 34% is unchanged) and kidneys (40%, of which about 5% is unchanged). The elimination half-life is between 10-15 hours. Excretion is delayed in renal failure. It has not been established whether cyproheptadine crosses the placental barrier and is excreted in breast milk.

B vitamins (B1, B2, B3 and B6).

It is well absorbed in the gastrointestinal tract. It is evenly distributed in most tissues and fluids. They are excreted through the kidneys.

 

Instructions for use

• In order to stimulate appetite and height growth.

• As a non-hormonal anabolic (for the purpose of increasing weight, muscle mass).

 

Contraindications

Individual hypersensitivity to cyproheptadine, group B vitamins or any of its excipients.

Hyperthyroidism.

Increased intraocular pressure.

Angle-closure glaucoma.

High blood pressure.

Acute asthma attack.

Conditions that prevent the emptying of the stomach (stenotic ulcer of the stomach, obstruction of the gastric outlet).

Conditions accompanied by difficulty urinating (hyperplasia of the prostate gland, stenosis of the bladder neck). 

Taking drugs from the group of MAO inhibitors (moclobemide, selegiline).

Chronic idiopathic constipation.

 

Special instructions and precautions

The drug should be used with caution in bronchial asthma, increased intraocular pressure, hyperthyroidism, cardiovascular diseases, and arterial hypertension.

Long-term therapy with cyproheptadine can rarely cause pathological changes in the blood.

The drug contains vitamin B6: the drug should be prescribed with caution in patients with kidney and liver failure.

Alcoholic beverages cannot be used during treatment.

 

Interaction with other drugs

Tell your doctor or pharmacist if you are currently taking, have recently taken or plan to take any medication.

Pyridoxine reduces the antiparkinsonian activity of levodopa and the neurotoxic effect of isoniazid.

Thiosemicarbazone and 5-fluorouracil are antagonists of thiamine and strongly weaken the effect of vitamin B1.

Antacids slow down the absorption of vitamin B1.

Cyproheptadine can cause relapse of depression when used together with antidepressants that are selective serotonin reuptake inhibitors.

Tricyclic antidepressants enhance the cholinolytic effect of cyproheptadine and its depressant effect on the central nervous system.

MAO inhibitors (moclobemide, selegiline) enhance the anticholinergic effect of cyproheptadine and prolong the duration of action.

Simultaneous use of the drug with sleeping pills, sedatives and anxiolytic drugs, as well as alcohol has an inhibitory effect on the CNS, therefore, it should be used with caution.

 

Use during pregnancy and lactation

Since there are not enough studies on the safety of the drug, it is not used in pregnant women and during lactation. If it is necessary to use the drug during lactation, breastfeeding should be temporarily stopped.

 

Effects on the ability to drive vehicles and other potentially dangerous mechanisms

Some side effects observed during treatment with cyproheptadine (dizziness, drowsiness, incoordination) can weaken the ability to concentrate and the copy of psychomotor reactions. When those reactions are observed, patients are not recommended to drive vehicles and other mechanisms.

 

Method of use and dosage

Trimetavit syrup is taken orally 30-60 minutes before meals. The preparation can be mixed with water or fruit juice. Shake the vial before use.

After use, it is necessary to close the lid of the vial.

Unless otherwise prescribed by a doctor, use the following doses:

Children up to 2 years: 2.5 ml 2 times a day

Use in children under 2 years of age is possible only with a doctor's prescription.

Children aged 2-6 years: 5 ml 2-3 times a day

Children aged 7-14 years: 10 ml 2-3 times a day

Children over 14 years and adults: 10 ml 3 times a day.

If necessary, the dose taken can be adjusted by the doctor.

The duration of treatment is determined by the doctor individually, but usually it is 2 months.

Side effects

As with all medicines, there may be unwanted side effects in people who are sensitive to any of the ingredients in the preparation. The drug is usually well received by the body. Side effects are usually mild and transient. Serious adverse reactions are very rare.

Common side effects: drowsiness, feeling tired, trouble sleeping (insomnia), dizziness, abdominal pain, nausea, diarrhea, constipation, dry mouth, throat, or nose, thickening of mucus in the nose or throat.

In rare cases, a sedative effect and drowsiness may be observed at the beginning of taking the drug.

This effect can be eliminated by reducing the dose, but this side effect usually goes away in 3-4 days.

If the following side effects occur while taking the drug, contact your doctor immediately (these unwanted effects may be related to taking cyproheptadine):

• mental disorders/mood changes (anxiety, agitation, hallucinations)

• shaking (tremor)

• difficult urination

• fast/irregular heartbeat.

Consult your doctor if unwanted effects occur.

If you experience any side effects not listed in this package insert, tell your doctor.

 

Overdose

In case of overdose, side effects may increase. During the use of the drug in children, central nervous system alertness was observed 30 minutes to 2 hours after administration.

Treatment: gastric lavage, general symptomatic and supportive therapy should be carried out.

 

Release form

Syrup for internal reception.

100 ml of solution in a vial. 1 vial is packed in a cardboard box with an insert.

 

Storage conditions

It should be stored at a temperature not higher than 25°C, in a dry place, protected from light and out of the reach of children. After use, it is necessary to close the lid of the vial.

 

Shelf life

2 years.

Do not use after the expiration date.

 

Condition of release from pharmacy

It is released without a prescription.

 

Producer

Opes Healthcare Pvt. Ltd., India.

11 Trimul Estate, Khatraj, Tal Kalol, Gandhinagar dist, Gujarat, India.

 

Holder of registration card

NES GROUP LTD, Republic of Azerbaijan.

A. Neymatulla street, Narimanov region, home 70A, flat 4, Baku, Azerbaijan, AZ1052.