Vaso Dose Pack

Chlorpheniramine maleate is an antihistamine having the chemical name 2-pyridinepropanamine, gamma-(4 chlorophenyl)-N, N-dimethyl-, (Z)-2-butenedioate (1:1).; C16H19ClN2•C4H4O4, MW = 390.86.

Pseudoephedrine hydrochloride is a nasal decongestant. Chemically it is [S-(R*,R*)]-α-[1(methylamino) ethyl]-benzenemethanol hydrochloride; C10H15NO•HCl, MW = 201.7.

Methscopolamine nitrate is an anticholinergic having the chemical name 3-oxa-9-azoniatricyclo [3.3.1.0 2 4] nonane, 7-(3-hydroxy-1-oxo-2-phenylpropoxy)-9, 9-dimethyl-, nitrate, [7(S)-(1α, 2β,4β, 5α, 7β)]; C17H21NO4•CH3NO3, MW = 380.4.

Inactive Ingredients

Each white tablet contains: dicalcium phosphate, hydrogenated cottonseed oil, hydroxypropyl methylcellulose, stearic acid, silicon dioxide, and magnesium stearate.

Each green tablet contains: calcium phosphate, hydrogenated cottonseed oil, hydroxypropyl methylcellulose, stearic acid, magnesium stearate, silicon dioxide, hydroxypropyl cellulose, D & C yellow lake # 10, FD & C blue lake #1.

For the temporary relief of symptoms associated with allergic rhinitis, vasomotor rhinitis, and the common cold.

General

Vaso should be used with caution in patients with diabetes mellitus, hypertension, cardiovascular disease, and hyperactivity to sympathomimetic amines. Antihistamines may cause drowsiness, and ambulatory patients who operate machinery or motor vehicles should be cautioned accordingly. Methscopolamine nitrate should be used with caution in the elderly and all patients with autonomic neuropathy, hepatic or renal disease, or ulcerative colitis.

Drug Interactions

Do not prescribe Vaso for use in patients that are now taking prescription MAOIs (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 14 days after stopping MAOI drug therapy. Beta-adrenergic blockers and MAOIs may potentiate the pressor effect of pseudoephedrine HCl. Concurrent use of digitalis glycosides may increase the possibility of cardiac arrhythmias. Sympathomimetics may reduce the hypotensive effects of guanethidine, mecamylamine, methyldopa, reserpine and veratrum alkaloids. Concurrent use of pseudoephedrine HCl with other sympathomimetic amines may increase pressor or cardiovascular effects of either medication.

The use of pseudoephedrine HCl may result in additive CNS depressant effects when coadministered with alcohol, antihistamines, psychotropics, or other drugs which produce CNS depression. Concurrent use of tricyclic antidepressants may antagonize the effects of pseudoephedrine HCl.

Additive anticholinergic effects may result from concomitant use with antipsychotics, tricyclic antidepressants, and other drugs with anticholinergic effects. Concomitant administration with antacids may interfere with the absorption of methscopolamine nitrate.

Carcinogenesis,Mutagenesis, Impairment of Fertility

Animal studies to assess the long-term carcinogenic and mutagenic potential or the effect on fertility in animals or humans have not been performed.

Pregnancy: Category C

It is not known whether Vaso can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Vaso should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether this combination drug is excreted in human milk. However, pseudoephedrine HCl administered alone distributes into the breast milk of lactating human females; therefore, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

The safety and effectiveness in children under 12 years of age have not been established.

Geriatric Use

The elderly (60 years and older) are more likely to experience adverse reactions to sympathomimetics. Overdosage of sympathomimetics in this age group may cause hallucinations, convulsions, CNS depression, and/or death. Pseudoephedrine HCl is known to be substantially excreted by the kidneys and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

ADVERSE REACTIONS

Adverse reactions include drowsiness, lassitude, nausea, giddiness, dryness of mouth, blurred vision, cardiac palpitations, flushing, and increased irritability or excitement (especially in children). Some individuals may display sympathomimetic amine effects such as tachycardia, palpitations, headache, dizziness, or nausea. Sympathomimetics have been associated with certain untoward reactions including fear, anxiety, nervousness, restlessness, tremor, weakness, pallor, respiratory difficulty, dysuria, insomnia, hallucinations, convulsions, CNS depression, arrhythmias, and cardiovascular collapse with hypotension. Urinary retention may occur in patients with prostatic hypertrophy. Antihistamines and anticholinergics may cause drowsiness, dizziness, blurred vision, and excessive dryness of the nose, throat, and mouth.

DRUG ABUSE AND DEPENDENCE

Rebound congestion may occur after vasoconstriction subsides when pseudoephedrine HCl is discontinued. Patients may increase the amount of drug and frequency of use, producing toxicity and perpetuating the rebound congestion. Excessive use may cause systemic effects which are more likely in the elderly. Habituation and toxic psychosis have followed long-term, high-dose therapy.

OVERDOSAGE AND TREATMENT OF OVERDOSAGE

The treatment of overdosage should provide symptomatic and supportive care. Induction of emesis and gastric lavage may be performed if the patient is alert and seen within early hours after ingestion. Drug remaining in the stomach may be absorbed by the administration of activated charcoal. Stimulants should not be used because they may precipitate convulsions. If convulsions or marked CNS excitement occurs, treatment with appropriate measures is indicated. Since the effects of Vaso last up to 12 hours, the patient should be monitored for at least that length of time and treated as necessary.

DOSAGE AND ADMINISTRATION

Adults and children 12 years of age and over: One White AM tablet in the morning and one Green PM tablet in the evening. Vaso is not recommended for children under 12 years of age.

Vaso Dose Pack 10 (NDC 43351-002-20), containing 20 controlled-release tablets in one (1) blister card as follows:

10 White AM, oval tablets with “VP” scored “7” on one side and plain on the other side, each containing 120 mg of pseudoephedrine HCl and 2.5 mg of methscopolamine nitrate.

10 Green PM, oval tablets with “VP” scored “6” on one side and plain on the other side, each containing 8 mg of chlorpheniramine maleate and 2.5 mg of methscopolamine nitrate.

Vaso Dose Pack 30 (NDC 43351-002-60), containing 60 controlled-release tablets in three (3) blister card as follows:

30 White AM, oval tablets with “VP” scored “7” on one side and plain on the other side, each containing 120 mg of pseudoephedrine HCl and 2.5 mg of methscopolamine nitrate.

30 Green PM, oval tablets with “VP” scored “6” on one side and plain on the other side, each containing 8 mg of chlorpheniramine maleate and 2.5 mg of methscopolamine nitrate.

Keep this and all medications out of the reach of children.

Store at 20-25°C (68°-77°F) excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Manufactured for:
Allaire Pharmaceuticals, LLC
Estero, FL 33928
www.allairepharmaceuticals.com

By:
Nexgen Pharma, Inc.
17802 Gillette Avenue
Irvine, CA 92614

Vaso Dose Pack 10 Blister Pack Display

NDC 43351-002-20

Vaso Dose Pack 10

Each Complete Dose Pack Contains 10 white tablets and 10 green tablets.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Store at controlled room temperature between 20°- 25° C (68°- 77° F).

Vaso Dose Pack 30 Blister Pack Display

NDC 43351-002-60

Vaso Dose Pack 30

Each Complete Dose Pack Contains 30 white tablets and 30 green tablets.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Store at controlled room temperature between 20°- 25° C (68°- 77° F).