DRUG CLASS:
Antihistamines; Antineoplastics; Antitussives/Expectorants; Cold Remedies; Nasal
Decongestants
BRAND NAMES:
Histatan (US); R-Tannamine (US);
R-Tannate (US); Rhinatate (US);
Rynatan (US); Tanamine (US);
Tri-Tannate (US); Triotann (US);
Tritan (US); Url-Tannate (US);
DESCRIPTION:
This combination drug is an antihistamine/nasal decongestant combination
available for oral administration as tablets and as pediatric suspension.
Each Tablet Contains: Phenylephrine Tannate: 25 mg; Chlorpheniramine
Tannate: 8 mg; Pyrilamine Tannate: 25 mg; Other ingredients:
Corn starch, dibasic calcium phosphate, magnesium stearate, methylcellulose,
polygalacturonic acid, talc.
Each 5 ml (teaspoonful) of the Pediatric Suspension contains: Phenylephrine
Tannate: 5 mg; Chlorpheniramine Tannate: 2 mg; Pyrilamine Tannate:
12.5 mg
Other Ingredients: Benzoic acid, FD&C red no. 3, flavors (natural
and artificial), glycerin, kaolin, magnesium aluminum silicate, methylparaben,
pectin, purified water, saccharin sodium, sucrose.
CLINICAL PHARMACOLOGY:
This combination drug combines the sympathomimetic decongestant effect of
phenylephrine with the antihistaminic actions of chlorpheniramine and pyrilamine.
INDICATIONS AND USAGE:
This combination drug is indicated for symptomatic relief of the coryza and
nasal congestion associated with the common cold, sinusitis, allergic rhinitis
and other upper respiratory tract conditions. Appropriate therapy should be
provided for the primary disease.
CONTRAINDICATIONS:
This combination drug is contraindicated for newborns, nursing mothers and
patients sensitive to any of the ingredients or related compounds.
WARNINGS:
Use with caution in patients with hypertension, cardiovascular disease,
hyperthyroidism, diabetes, narrow angle glaucoma or prostatic hypertrophy. Use
with caution or avoid use in patients taking monoamine oxidase (MAO) inhibitors.
This product contains antihistamines which may cause drowsiness and may have
additive central nervous system (CNS) effects with alcohol or other CNS
depressants (e.g., hypnotics, sedatives, tranquilizers).
PRECAUTIONS:
General
Antihistamines are more likely to cause dizziness, sedation and hypotension
in elderly patients. Antihistamines may cause excitation, particularly in
children, but their combination with sympathomimetics may cause either mild
stimulation or mild sedation.
Information for the Patient
Caution patients against drinking alcoholic beverages or engaging in
potentially hazardous activities requiring alertness, such as driving a car or
operating machinery, while using this product.
Carcinogenesis, Mutagenesis, and Impairment of Fertility
No long term animal studies have been performed with this combination drug.
Pregnancy, Teratogenic Effects, Pregnancy Category C
Animal reproduction studies have not been conducted with this combination
drug. It is also now known whether this combination drug can cause fetal harm
when administered to a pregnant woman or can affect reproduction capacity. This
combination drug should be given to a pregnant woman only if clearly needed.
Nursing Mothers
This combination drug should not be administered to a nursing woman.
DRUG INTERACTIONS:
MAO inhibitors may prolong and intensify the anticholinergic effects of
antihistamines and the overall effects of sympathomimetic agents.
ADVERSE REACTIONS:
Adverse effects associated with this combination drug at recommended doses
have been minimal. The most common have been drowsiness, sedation, dryness of
mucous membranes and gastrointestinal effects. Serious side effects with oral
antihistamines or sympathomimetics have been rare.
OVERDOSAGE:
Signs and Symptoms
May vary from CNS depression to stimulation (restlessness to convulsions).
Antihistamine overdosage in young children may lead to convulsions and death.
Atropine-like signs and symptoms may be prominent.
Treatment
Induce vomiting if it has not occurred spontaneously. Precautions must be
taken against aspiration especially in infants, children and comatose patients.
If gastric lavage is indicated, isotonic or half-isotonic saline solution is
preferred. Stimulants should not be used. If hypotension is a problem,
vasopressor agents may be considered.
DOSAGE AND ADMINISTRATION:
Administer the recommended dose every 12 hours.
Tablets
Adults: 1 or 2 tablets.
Pediatric Suspension
Children Over Six Years of Age: 5-10 ml (1-2 teaspoonfuls).
Children Two to Six Years of Age: 2.5-5 ml (½-1 teaspoonful).
Children Under Two Years of Age: Titrate dose individually.
Storage: Store at controlled room temperature between 15-30°C (59-86°F);
protect from freezing.
Dispense in tight container.
