Rynatan

Indications : Common cold; Congestion, nasal; Infection, sinus; Rhinitis, seasonal allergic

Pregnancy Category C

FDA Pre 1938 Drugs

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.

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