Tripohist

triprolidine hydrochloride

Dosage Form: oral liquid
Tripohist™ Liquid

Antihistamine

Tripohist Description

Tripohist™ Liquid is an alcohol free, sugar free red syrup for oral administration having an apple odor and flavor.

Each teaspoonful (5 mL) contains:

Triprolidine Hydrochloride

1.25 mg

INACTIVE INGREDIENTS

Sodium Benzoate, Citric Acid, Saccharin Sodium, Glycerin, Sorbitol Solution, Apple Flavor, FD&C Red No. 40 and Purified Water.

Triprolidine Hydrochloride is an antihistamine, chemically it is: Pyridine, 2-[1-(4-methyl-phenyl)-3-(1-pyrrolidinyl)-1-propenyl]-, monohydrochloride, monohydrate, (E)-. It's structure is as follows:

C19H22N2•HCl•H2O             M.W. 332.87

Tripohist - Clinical Pharmacology

Triprolidine provides symptomatic relief of conditions believed to depend wholly or partly upon the release of histamine. Triprolidine hydrochloride antagonizes the effects of histamine by competing for histamine-1 (H1) receptor sites. The serum half-life for triprolidine is 3 to 3.3 hours.

Indications and Usage for Tripohist

Triprolidine provides symptomatic relief of perennial and seasonal allergic rhinitis, vasomotor rhinitis, allergic conjunctivitis due to inhalant allergens and foods, and mild uncomplicated allergic skin manifestations of urticaria and angioedema.

Contraindications

Tripohist™ Liquid is contraindicated in individuals who have a known hypersensitivity to triprolidine HCl or any of its ingredients.

Warnings

Do not exceed recommended dosage. If nervousness, dizziness, or sleeplessness occurs, discontinue use and consult a physician. If symptoms do not improve within 7 days or are accompanied by a fever, consult a physician. Do not take this product, unless directed by a physician, if you have a breathing problem such as emphysema or chronic bronchitis, or if you have glaucoma or difficulty in urination due to enlargement of the prostate gland. May cause drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect. Avoid alcoholic beverages while taking this product. Do not take this product if you are taking sedatives or tranquilizers, without first consulting your physician. Use caution when driving a motor vehicle or operating machinery.

Antihistamines should be used with considerable caution in patients with glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction, symptomatic prostatic hypertrophy, and bladder neck obstruction.

Pediatric Use

See PRECAUTIONS, Pediatric Use

This product may cause excitability especially in children.

Do not give this product to children who have a breathing problem such as chronic bronchitis, or who have glaucoma, without first consulting the child's physician.

This product may cause drowsiness. Sedatives and tranquilizers may increase the drowsiness effect. Do not give this product to children who are taking sedatives or tranquilizers, without first consulting the child's physician.

Precautions

Drug Interactions

MAO inhibitors (or for 14 days after stopping MAOI therapy) and tricyclic antidepressants may prolong and intensify the anticholinergic (drying) effects of antihistamines. Concomitant use of antihistamines with tricyclic antidepressants, barbiturates, and other CNS depressants may have an additive effect. Antihistamines should be used with considerable caution in patients with history of bronchial asthma, increased intraocular pressure, hyperthyroidism, cardiovascular disease and hypertension.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No adequate or well controlled studies have been conducted to determine whether the components of Tripohist™ Liquid have a potential for carcinogenesis, mutagenesis, or impairment of fertility.

Pregnancy

Pregnancy Category C

Animal reproduction studies have not been conducted with this product. It is not known whether it can cause fetal harm when administered to a pregnant women or can effect reproduction capacity. This product should not be administered to pregnant women.

Nursing Mothers

Due to the possible passage of the ingredients into breast milk, this product should not be given to nursing mothers.

Pediatric Use

Safety and effectiveness in the pediatric population, under 6, have not been established.

Adverse Reactions

Possible side effects of antihistamines are drowsiness, dry mouth, anorexia, nausea, vomiting, headache, dizziness, nervousness, blurred vision, polyuria, heartburn, dysuria, urinary retention and very rarely, dermatitis.

Overdosage

Signs and Symptoms

Manifestations of antihistamine overdosage may vary from CNS depression (sedation, apnea, cardiovascular collapse) to stimulation (insomnia, hallucinations, tremors or convulsions). Other signs and symptoms may be dizziness, tinnitus, blurred vision and hypotension. Stimulation is particularly likely in children, as are atropine-like signs and symptoms.

Treatment

Treatment of the signs and symptoms of overdosage is symptomatic and supportive. The patient should be induced to vomit, even if emesis has occurred spontaneously. Pharmacologic vomiting by the administration of ipecac syrup is a preferred method, however, vomiting should not be induced in patients with impaired consciousness. Precautions against aspiration must be taken, especially in infants and children. Following emesis, any drug remaining in the stomach may be absorbed by activated charcoal administered as a slurry with water.

Tripohist Dosage and Administration

Adults

2 Teaspoonfuls every 4 to 6 hours not to exceed 4 doses in a 24 hour period.

Children 6 to 12

1 Teaspoonful every 4 to 6 hours not to exceed 4 doses in a 24 hour period.

This product is not indicated for use in children under 6 years of age. (see PRECAUTIONS, Pediatric Use.)

How is Tripohist Supplied

Tripohist™ Liquid is supplied as a sugar free, alcohol free, red, apple flavored liquid in bottles of 16 fl.oz. (One Pint), NDC 51991-531-16.

WARNING: KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

Storage

Store at 25°C(77°F); excursions permitted to 15°-30°C(59°-86°F). See USP Controlled Room Temperature. Protect from freezing.

Pharmacist: Dispense in a tight, light-resistant container with a child-resistant closure as defined in the USP/NF.

All prescription substitutions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product.

Rx ONLY

Distributed by:

Breckenridge Pharmaceutical, Inc.

Boca Raton, FL 33487

Manufactured by:

Tri-Med Laboratories, Inc.

Somerset, NJ 08873

Iss. 10/07

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

Breckenridge

Pharmaceutical, Inc.

NDC 51991-531-16

Tripohist™

Liquid

• Sugar Free


• Alcohol Free

Description: Each 5 mL (one teaspoonful) for oral

administration contains:

Triprolidine Hydrochloride                     1.25 mg

INACTIVE INGREDIENTS: Sodium Benzoate,

Citric Acid, Saccharin Sodium, Glycerin, Sorbitol

Solution, Apple Flavor, FD&C Red No. 40, Purified

Water.

Rx Only

Net Contents:

16 fl. oz. (One Pint) 473 mL

Tripohist  triprolidine hydrochloride  liquid

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 51991-531 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Triprolidine Hydrochloride (Triprolidine) Triprolidine Hydrochloride 1.25 mg  in 5 mL

Inactive Ingredients Ingredient Name Strength sodium benzoate   citric acid monohydrate   saccharin sodium   glycerin   sorbitol   FD&C Red No. 40   water

Product Characteristics Color PINK (Clear reddish-pink) Score      Shape Size Flavor APPLE Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 51991-531-16 473 mL In 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		01/31/2008	12/31/2011

Labeler - Breckenridge Pharmaceutical, Inc. (150554335)

Establishment
Name	Address	ID/FEI	Operations
TriMed Laboratories, Inc.		182050567	MANUFACTURE

Revised: 10/2010Breckenridge Pharmaceutical, Inc.

More Tripohist resources

• Tripohist Side Effects (in more detail)
• Tripohist Dosage
• Tripohist Use in Pregnancy & Breastfeeding
• Tripohist Drug Interactions
• Tripohist Support Group
• 0 Reviews for Tripohist - Add your own review/rating

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Compare Tripohist with other medications

• Allergic Urticaria
• Allergies
• Conjunctivitis, Allergic
• Eye Redness/Itching
• Hay Fever
• Rhinorrhea