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Composition:


active ingredient: clemastine;


1 ml of the solution contains clemastine fumarate 1.34 MG, which corresponds to 1 mg of clemastine;


excipients: sorbitol (E 420), ethanol 96%, propylene glycol, sodium citrate, water for injection.


Dosage form. Solution for injection.


Basic physical and chemical properties: clear, colorless or yellowish solution.


Pharmacotherapeutic group. Antihistamines for systemic use.


ATX code R06A A04.


Pharmacological properties.


Pharmacodynamics.


Tavegil is an H1 receptor antagonist. It belongs to antihistamines of the group of benzydryl esters. Tavegil selectively inhibits histamine H1 receptors and reduces capillary permeability. It has a pronounced antihistamine and antipruritic effect, characterized by a rapid onset and a significant duration (up to 12 hours).


Pharmacokinetics.


The Binding of clemastine to plasma proteins is approximately 95 %.


Clemastine is metabolized in the liver. Elimination from the body occurs in two phases: the Half – Life of the first phase is on average 3.6 ± 0.9 hours; the second phase-37 ± 16 hours. Metabolites in large quantities (45-65 %) are excreted by the kidneys in the urine. Unchanged active substance is found in the urine only in small amounts. In women during breast-feeding, a small amount of the drug can enter breast milk.


Clinical characteristics.


Indications.


Prevention and treatment of allergic and pseudoallergic reactions, including reactions to the introduction of contrast agents, blood transfusions, diagnostic use of histamine.


Secondary treatment (after intramuscular administration of epinephrine at a dose of 0.01 mg/kg) in case of anaphylactic or anaphylactoid shock and angioedema.


Contraindications. Hypersensitivity to clemastine or to excipients of the drug, as well as to antihistamines of a similar chemical structure. Porphyria.


Interactions with other drugs and other types of interactions.


Antihistamines potentiate the sedative effect of drugs that depress the central nervous system (sleeping pills, antidepressants, both tricyclic and monoamine oxidase inhibitors (MAOIs), anxiolytics, opioid analgesics, and alcohol). During the use of the drug, it is necessary to avoid the use of alcoholic beverages.


Application features.


The drug in this dosage form can show a more pronounced sedative effect than in tablets for oral administration, especially in young children. Intravenous injections should be given slowly (within 2-3 minutes).


Tavegil should be used with caution in patients with angle-closure glaucoma, peptic ulcer in the presence of stenosis, pyloroduodenal stenosis, prostatic hypertrophy with urinary retention and obstruction of the bladder neck.


The drug contains sorbitol, so it should not be used in patients with hereditary fructose intolerance.


The drug contains ethanol 96% - 140 mg in 2 ml (1 ampoule). It can be harmful for people suffering from alcoholism. The ethanol content should be taken into account when using the drug in children and patients belonging to high-risk groups, such as patients with liver disease or epilepsy.


Use during pregnancy or lactation.


Tavegil should not be used during pregnancy or lactation, unless the drug is prescribed by a doctor or healthcare professional.


Ability to influence the reaction rate when driving vehicles or other mechanisms.


Due to the antihistamine sedative effect of clemastine and the likelihood of adverse reactions from the nervous system, Tavegil may moderately affect the ability to drive vehicles or other mechanisms.


Dosage and administration.


Adults and children over 12 years of age should be administered intravenously slowly (within 2-3 minutes) or intramuscularly in a single dose of 2 ml (contents of 1 ampoule) – 2 times a day (morning and evening). Intra-arterial administration of the drug is strictly prohibited!


To prevent allergic reactions, administer 2 ml of Tavegil slowly intravenously immediately before the possible development of an anaphylactic reaction or a reaction to histamine. The solution can be diluted with 0.9% sodium chloride solution or 5% glucose solution in a ratio of 1:5. children aged 1 to 12 years should be administered intramuscularly at a daily dose of 0.025 mg/kg of body weight 2 times a day.


Children. Tavegil should not be used in children under 1 year of age.


Overdose. Symptoms of both central nervous system depression and agitation may occur, such as depression of consciousness, agitation, hallucinations, or seizures. Anticholinergic symptoms such as dry mouth, fixed pupil dilation, hyperemia, digestive tract disorders, and tachycardia are also possible.


Treatment. Therapy is symptomatic.


Adverse reactions.


The side effects listed below are classified by frequency: very common (≥1/10), common (≥1/100,


unknown (the frequency cannot be estimated from the available data).


From the central nervous system: often – a feeling of fatigue, sedation, drowsiness; infrequently – dizziness; rarely – headache.


From the side of the psyche: rarely – arousal, especially in children.


From the digestive system: rarely – gastrointestinal disorders, including epigastric pain, nausea, dry mouth; very rarely – constipation.


From the immune system: infrequently – hypersensitivity reactions, shortness of breath; rarely – anaphylactic shock.


From the skin: rarely-skin rashes.


From the cardiovascular system: very rarely-tachycardia, palpitations.


Common disorders: rarely-asthenia.


It is important to report suspected adverse reactions to your doctor. This makes it possible to continue monitoring the benefit/risk ratio of the drug.

Tags: Tavegil [Clemastine]