Trisulfaminic (Phenylpropanolamine HCl and Pheniramine Maleate)

TRISULFAMINIC Shepherd Triple Sulfas–Phenylpropanolamine HCl Compound–Pheniramine Maleate Decongestant–Antibacterial

Indications And Clinical Uses:

Congestion and infection of upper respiratory tract caused by sulfa-susceptible organisms.

Contra-Indications:

Sensitivity to any of the components, impaired renal function, pregnancy approaching term, and in premature infants and newborn infants during the first month of life. Do not use in patients with glaucoma, prostatic hypertrophy, stenosing peptic ulcer, pyloroduodenal or bladder neck obstruction or patients receiving MAO inhibitors.

Precautions:

Use with caution in patients with histories of significant allergy or asthma or patients receiving methyldopa or beta adrenergic blockers. Assure an adequate fluid intake.

Occupational Hazards: Patients should be cautioned not to operate vehicles or hazardous machinery until their response to the drug has been determined.

Since the depressant effects oif antihistamines are additive to those of other drugs affecting the CNS, patients should be cautioned against drinking alcoholic beverages or taking hypnotics, sedatives, psychotherapeutic agents or other drugs with CNS depressant effects during antihistaminic therapy.

Use with caution in the presence of hypertension, hyperthyoidism, cardiovascular disease and diabetes mellitus. Use only after careful evaluation in patients with liver or renal damage, urinary obstruction, or blood dyscrasias. In intermittent or prolonged therapy, blood counts and liver and kidney function tests should be performed periodically. Sulfonamide therapy may potentiate the hypoglycemic action of sulfonylureas and induce hemolytic anemia in patients with a deficiency of glucose-6-phosphate dehydrogenase.

Adverse Reactions:

As in all sulfonamide therapy, the following reactions may occur: headache, nausea, vomiting, diarrhea, icterus, hepatitis, pancreatitis, urticaria, rash, fever, cyanosis, hematuria, crystalluria, proteinuria, blood dyscrasias, petechiae, purpura, neuropathy and injection of the conjunctiva and sclera. If any of these reactions occur, the drug should be discontinued.

With antihistaminic therapy there have been reports of sedation varying from mild drowsiness to deep sleep, dizziness, lassitude, inability to concentrate, fatigue, incoordination, tinnitus, blurred vision, diplopia, euphoria, nervousness, insomnia, tremors, palpitation, hypotension, headache, chest tightness, urinary frequency, dysuria, tingling of the hands, dryness of the mouth, throat, and nose, gastrointestinal disturbances such as epigastric distress, anorexia, nausea, vomiting, constipation and diarrhea and very rarely, leukopenia and agranulocytosis.

Adverse effects reported with the use of sympathomimetic amines include anxiety, tension, restlessness, nervousness, tremor, weakness, insomnia, headache, palpitation, tachycardia, angina, elevation of blood pressure, sweating, mydriasis, anorexia, nausea, vomiting, dizziness, constipation, and dysuria due to vesicle sphincter spasm.

Dosage And Administration:

Adults: 10 to 20 mL or 2 to 4 tablets initially, followed by 10 mL or 2 tablets every 6 hours. Children: 8 to 12 years: 10 mL or 2 tablets initially, followed by 5 mL or 1 tablet every 6 hours; 3 to 7 years: 5 mL every 6 hours; 1 to 2 years: 2.5 mL every 6 hours.

Medication should be continued until patient has been afebrile for 3 days.

Availability And Storage:

Suspension: Each 5 mL of orange-colored suspension contains: phenylpropanolamine HCl 12.5 mg, pheniramine maleate 6.25 mg, pyrilamine maleate 6.25 mg, sulfadiazine 167 mg, sulfamerazine 167 mg and sulfamethazine 167 mg. Nonmedicinal ingredients: D&C Yellow, FD&C Red, menthol, methyl cellulose, orange concentrate, sodium benzoate, sorbitol, sucrose and water. Energy: 80.5 kJ (19.24 kcal)/5 mL. Sodium: <1 mmol (0.8 mg). Alcohol- and tartrazine-free. Bottles of 500 mL.

Tablets: Each capsule-shaped tablet contains: phenylpropanolamine HCl 12.5 mg, pheniramine maleate 6.25 mg, pyrilamine maleate 6.25 mg, sulfadiazine 167 mg, sulfamerazine 167 mg and sulfamethazine 167 mg. Nonmedicinal ingredients: acacia, cornstarch, D&C Yellow, guar gum, icing sugar, magnesium stearate, methylcellulose, sodium alginate, stearic acid and water. Sodium: <1 mmol (<5 mg). Tartrazine-free. Bottles of 100 and 500.

TRISULFAMINIC Shepherd Triple Sulfas–Phenylpropanolamine HCl Compound–Pheniramine Maleate Decongestant–Antibacterial