Tavegil

Tavegile Fumarate Syrup is indicated for the relief of symptoms associated with allergic rhinitis such as sneezing, rhinorrhea, pruritus and lacrimation. Tavegile Fumarate Syrup is indicated for use in pediatric populations (age 6 years through 12) and adults (see DOSAGE AND ADMINISTRATION).

It should be noted that Tavegile is indicated for the relief of mild uncomplicated allergic skin manifestations of urticaria and angioedema at the 2 mg dosage level only.

DOSIERUNG SOLLTE NACH DEN BEDÜRFNISSEN UND ANTWORT DES PATIENTEN EINZELN

Pädiatrisch

Erwachsene und Kinder ab 12 Jahren

Für Symptome einer allergischen Rhinitis - Die Anfangsdosis beträgt zweimal täglich 2 Teelöffel (1 mgTavegile). Die Dosierung kann nach Bedarf erhöht werden, darf jedoch 12 Teelöffel täglich (6 mg Tavegile) nicht überschreiten.

Für Urtikaria und Angioödem - Die Anfangsdosis beträgt zweimal täglich 4 Teelöffel (2 mg Tavegile), höchstens 12 Teelöffel täglich (6 mg Tavegile).

Antihistamines are contraindicated in patients hypersensitive to the drug or to other antihistamines of similar chemical structure (see PRECAUTIONS: DRUG INTERACTIONS).

Antihistamines should not be used in newborn or premature infants. Because of the higher risk of antihistamines for infants generally and for newborns and prematures in particular, antihistamine therapy is contraindicated in nursing mothers (see PRECAUTIONS-Nursing Mothers).

Antihistamine overdosage reactions may vary from central nervous system depression to stimulation. In children, stimulation predominates initially in a syndrome which may include exclient, hallucinations, ataxia, incoordination, muscle twitching, athetosis, hyperthermia, cyanosis convulsions, tremors, and hyperreflexia followed by postictal depression and cardio-respiratory arrest. Convulsions in children may be preceded by mild depression. Dry mouth, fixed dilated pupils, flushing of the face, and fever are common. In adults, CNS depression, ranging from drowsiness to coma, is more common. The convulsant dose of antihistamines lies near the lethal dose. Convulsions indicate a poor prognosis.

In both children and adults, coma and cardiovascular collapse may occur. Deaths are reported especially in infants and children.

There is no specific therapy for acute overdosage with antihistamines. The latent period from ingestion to appearance of toxic effects is characteristically short (1/2-2 hours). General symptomatic and supportive measures should be instituted promptly and maintained for as long as necessary.

Since overdoses of other classes of drugs (i.e. tricyclic antidepressants) may also present anticholinergic symptomatology, appropriate toxicological analysis should be performed as soon as possible to identify the causative agent.

In the conscious patient, vomiting should be induced even though it may have occurred spontaneously. If vomiting cannot be induced, gastric lavage is indicated. Adequate precautions must be taken to protect against aspiration, especially in infants and children. Charcoal slurry or other suitable agents should be instilled into the stomach after vomiting or lavage. Saline cathartics or milk of magnesia may be of additional benefit.

In the unconscious patient, the airway should be secured with a cuffed endotracheal tube before attempting to evacuate the gastric spans. Intensive supportive and nursing care is indicated, as for any comatose patient.

If breathing is significantly impaired, maintenance of an adequate airway and mechanical support of respiration is the most effective means of providing adequate oxygenation.

Hypotension is an early sign of impending cardiovascular collapse and should be treated vigorously. Although general supportive measures are important, specific treatment with intravenous infusion of a vasopressor titrated to maintain adequate blood pressure may be necessary.

Do not use with CNS stimulants.

Convulsions should be controlled by careful administration of diazepam or a short-acting barbiturate, repeated as necessary. Physostigmine may also be considered for use in controlling centrally mediated convulsions.

Ice packs and cooling sponge baths, not alcohol, can aid in reducing the fever commonly seen in children. A more detailed review of antihistamine toxicology and overdose management is available in Gosselin, R.E., et. al., "Clinical Toxicology of Commercial Products."