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Tripohist D

Generic Name: triprolidine hydrochloride and pseudoephedrine hydrochloride
Dosage Form: oral liquid

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Tripohist™ D Liquid
Antihistamine/Decongestant

Tripohist D Description

Tripohist™ D Liquid is an alcohol free, sugar free blue liquid for oral administration having an blueberry odor and flavor.

Each teaspoonful (5 mL) contains:

Triprolidine Hydrochloride 1.25 mg
Pseudoephedrine Hydrochloride 45 mg

INACTIVE INGREDIENTS

Sodium Benzoate, Citric Acid, Saccharin Sodium, Glycerin, Sorbitol Solution, Blueberry Flavor, FD&C Blue No. 1 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

Pseudoephedrine Hydrochloride is a nasal decongestant, chemically it is Benzenemethanol, α-[1-(methylamino)ethyl]-, [S-(R*,R*)]-, hydrochloride. It's structure is as follows:

C10H15NO•HCl    M.W. 201.69

Tripohist D - Clinical Pharmacology

Triprolidine hydrochloride is an antihistamine, which has anticholinergic (drying) and sedative effects. Triprolidine hydrochloride is promptly absorbed and rapidly reaches a therapeutic level which is usually maintained for 4-8 hours. It acts as an antagonist H1 histamine receptor. The serum half-life for triprolidine is 3 to 3.3 hours.

Pseudoephedrine Hydrochloride is an oral sympathomimetic amine that acts as a decongestant to respiratory tract mucous membranes. While its vasoconstrictor action is similar to that of ephedrine, pseudoephedrine has less pressor effect in normotensive adults. Serum half-life for pseudoephedrine is 6-8 hours. Acidic urine is associated with faster elimination of the drug. About one half of the administered dose is excreted in the urine.

Indications and Usage for Tripohist D

Tripohist™ D Liquid is indicated for the symptomatic treatment of perennial and seasonal allergic rhinitis and vasomotor rhinitis.

Contraindications

Tripohist™ D Liquid is contraindicated in patients with hypersensitivity or idiosyncrasy to: triprolidine hydrochloride and other antihistamines of similar chemical structure and/or sympathomimetic amines including pseudoephedrine and/or any of its ingredients; (MAO) inhibitors (or for 14 days after stopping MAOI therapy) and/or beta-adrenergic blocking agents; newborn or premature infants; nursing mothers; patients with severe hypertension or coronary artery disease; patients experiencing asthma attacks.

Warnings

Do not exceed recommended dosage. If nervousness, dizziness, or sleeplessness occurs, discontinue use and consult a doctor. If symptoms do not improve within 7 days or are accompanied by a fever, consult a doctor. Tripohist™ D Liquid should be used with considerable caution in patients with glaucoma; stenosing peptic ulcer; pyloroduodenal obstruction; prostatic hypertrophy; bladder neck obstruction; hypertension; diabetes mellitus; ischemic heart disease and hyperthyroidism. Sympathomimetics may produce CNS stimulation and convulsions or cardiovascular collapse with accompanying hypotension. 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. Pseudoephedrine is banned and tested for by the U.S. Olympic Committee.

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

Antihistamines should be used with caution in patients with history of bronchial asthma, increased intraocular pressure; diabetes mellitus; hyperthyroidism; cardiovascular disease and hypertension. Avoid alcohol and other CNS depressants while taking this product. Patients sensitive to antihistamines may experience drowsiness. Patients sensitive to sympathomimetic amines may experience CNS stimulation. While taking this product, exercise care in driving a motorized vehicle or operating machinery.

Drug Interactions

Antihistamines may enhance the effects of tricyclic antidepressants, barbiturates, alcohol, and other CNS depressants. MAO inhibitors prolong and intensify the anticholinergic (drying) effects of antihistamines. Sympathomimetic amines may reduce the antihypertensive effects of reserpine, veratrum alkaloids, methyldopa, mecamylamine. Effects of sympathomimetics are increased with MAO inhibitors (or for 14 days after stopping MAOI therapy), beta-adrenergic blocking agents, and thyroid hormones.

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 woman or can affect reproductive capacity. This product should be administered to pregnant women only if clearly needed.

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.

Geriatric Use

Antihistamines are more likely to cause dizziness, sedation, and hypotension in elderly patients (approximately 60 years or older). The elderly are also more likely to have adverse reactions to sympathomimetics, including hallucinations, convulsions, CNS depression, and death.

Adverse Reactions

The most frequent adverse reactions to antihistamines are sedation, dizziness, disturbed coordination, epigastric distress, and thickening of bronchial secretions. Others include vomiting, dry mouth, nervousness, nausea, anorexia, diplopia, polyuria, and diarrhea. Sympathomimetic amines may cause convulsions, CNS stimulation, cardiac arrhythmias, respiratory difficulty, tachycardia, palpitations, increased blood pressure, hallucinations, tremors, nervousness, insomnia, weakness, pallor, and dysuria.

Overdosage

No information is available as to specific results of an overdose on this product. The signs, symptoms, and treatment described below are those of H1 antihistamines and ephedrine overdose.

Signs and Symptoms

Should antihistamine effects predominate, central action constitutes the greatest danger. In the small child, symptoms include excitation, hallucination, ataxia, incoordination, tremors, flushing face and fever. Convulsions, fixed and dilated pupils, coma and death may occur in severe cases. In the adult, fever and flushing are uncommon; excitement leading to convulsions and postictal depression is often preceded by drowsiness and coma. Respiration is usually not seriously depressed; blood pressure is usually stable.

Should sympathomimetic symptoms predominate, central effects include restlessness, dizziness, tremor, hyperactive reflexes, talkativeness, irritability and insomnia. Cardiovascular and renal effects include difficulty in micturition, headache, flushing, palpitation, cardiac arrhythmias, hypertension with subsequent hypotension and circulatory collapse. Gastrointestinal effects include dry mouth, metallic taste, anorexia, nausea, vomiting, diarrhea, and abdominal cramps.

Treatment

1) Evacuate stomach as condition warrants. Activated charcoal may be useful. 2) Maintain a non-stimulating environment. 3) Monitor cardiovascular status. 4) Physostigmine may reverse anticholinergic symptoms. 5) Do not give stimulants. 6) Reduce fever with cool sponging. 7) Support respiration. 8) Use sedative or anticonvulsants to control CNS excitation and convulsions. 9) Ammonium chloride may acidify the urine to increase excretion of pseudoephedrine. 10) Further care is symptomatic and supportive.

Tripohist D Dosage and Administration

Adults and children over 12 years of age

1-2 teaspoonfuls every 4 to 6 hours (Do not exceed 240 mg of pseudoephedrine HCI in 24 hours).

Children 6 to 12 years

½-1 teaspoonful every 4 to 6 hours (Do not exceed 120 mg of pseudoephedrine HCI in 24 hours). This product is not indicated for use in children under 6 years of age. (see PRECAUTIONS, Pediatric Use.)

How is Tripohist D Supplied

Tripohist™ D Liquid is supplied as an alcohol free, sugar free, blue liquid having a blueberry odor and flavor, in bottles of 16 fl.oz. (One Pint), NDC 51991-532-16.

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 51991-532-16

Tripohist™ D
Liquid

Antihistamine/Decongestant
 

  • Sugar Free
  • Alcohol Free

Description: Each 5 mL (one teaspoonful) for oral
administration contains:

Triprolidine Hydrochloride 1.25 mg
Pseudoephedrine Hydrochloride 45 mg

INACTIVE INGREDIENTS: Sodium Benzoate,
Citric Acid, Saccharin Sodium, Glycerin, Sorbitol
Solution, Blueberry Flavor, FD&C Blue No. 1,
Purified Water.

Rx Only

Net Contents:
16 fl. oz. (One Pint) 473 mL

Tripohist D 
triprolidine hydrochloride and pseudoephedrine hydrochloride liquid
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:51991-532
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
Pseudoephedrine Hydrochloride (Pseudoephedrine) Pseudoephedrine Hydrochloride 45 mg  in 5 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Benzoate  
Citric Acid Monohydrate  
Saccharin Sodium  
Glycerin  
Sorbitol  
FD&C Blue No. 1  
Water  
Product Characteristics
Color BLUE Score     
Shape Size
Flavor BLUEBERRY Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:51991-532-16 473 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 01/01/2008 12/31/2011
Labeler - Breckenridge Pharmaceutical, Inc. (150554335)
Establishment
Name Address ID/FEI Operations
Trimed 182050567 MANUFACTURE
Revised: 11/2010
 
Breckenridge Pharmaceutical, Inc.

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