DryMax

JayMac Pharmaceuticals LLC
Great Southern Laboratories

DryMax Syrup

FULL PRESCRIBING INFORMATION: CONTENTS*

• DryMax Syrup
• CLINICAL PHARMACOLOGY:
• INDICATIONS:
• DRYMAX CONTRAINDICATIONS:
• WARNINGS:
• PRECAUTIONS: General:
  • Information for Patients:
  • Laboratory Tests:
  • Drug Interactions:
  • Laboratory Test Interactions:
  • Carcinogenesis, Mutagenesis, Impairment of Fertility:
  • Pregnancy: Category C:
  • Labor and Delivery:
  • Nursing Mothers:
  • Pediatric Use:
  • Geriatric Use:
• DRYMAX ADVERSE REACTIONS:
• DRUG ABUSE AND DEPENDENCE
• OVERDOSAGE
• DRYMAX DOSAGE AND ADMINISTRATION:
• HOW SUPPLIED:
• PRODUCT PACKAGING:

FULL PRESCRIBING INFORMATION

DryMax Syrup

CLINICAL PHARMACOLOGY:

INDICATIONS:

CONTRAINDICATIONS:

WARNINGS:

PRECAUTIONS: General:

Information for Patients:

• Do not take more medication than the amount recommended.
• This medication should be used with caution during exercise or hot weather, overheating may result in heat stroke.
• Do not drive or operate machinery if drowsiness or dizziness occurs.
• Do not ingest alcoholic beverages, monoamine oxidase (MAO) inhibitors, or CNS depression-producing medications (hypnotics, sedatives, tranquilizers) while taking this medication.
• This medication possibly increases sensitivity of eyes to light.
  
• Methscopolamine nitrate may cause blurred vision.
• If a dose is missed, the medication should be taken as soon as possible unless it is almost time for the next dose. Do not double doses.
• This medication should be stored in a tight, light-resistant container at temperatures between 15^o-30^oC (59^o-86^oF).
• Keep all medications out of reach of children. In case of accidental overdose, seek professional assistance or contact a poison control center immediately. Caution patients about the signs of potential side effects, especially:
• Anticholinergic effects - clumsiness or unsteadiness; severe drowsiness; severe dryness of mouth, nose, or throat; flushing or redness of face; shortness of breath or trouble breathing.
• Blood dyscrasias-sore throat and fever; unusual bleeding or bruising; unusual tiredness or weakness.
• Fast or irregular heartbeat.
• Psychotic episodes.
• Tightness in chest.

Laboratory Tests:

Drug Interactions:

• Alkalizers, such as: calcium and/or magnesium-containing antacids; Carbonic anhydrase inhibitors; citrates; sodium bicarbonate-urinary excretion of anticholinergics may be delayed by alkalization of the urine, thus potentiating methscopolamine's therapeutic and/or side effects.
• α-adrenergic blocking agents or other medications with α-adrenergic blocking action - prior to administration of α-adrenergics may block the pressor response to pseudoephedrine, possibly resulting in severe hypotension; medications with α-adrenergic blocking action may decrease the pressor effect and shorten the duration of action of pseudoephedrine.
• Antacids or absorbent antidiarrheals-simultaneous use of these medications may reduce absorption of methscopolamine, resulting in decreased therapeutic effectiveness; doses of these medications should be spaced 2 or 3 hours apart from doses of methscopolamine.
• Anesthetics, hydrocarbon inhalation - Concurrent use of chloroform, cyclopropane, halothane, or trichloroethylene with pseudoephedrine may increase the risk of severe ventricular arrhythmias because these anesthetics greatly sensitize the myocardium to the effects of sympathomimetic amines; pseudoephedrine should be used with caution and in substantially reduced dosage in patients receiving these anesthetics. Enflurane, isoflurane, or methoxyflurane may also cause some sensitization of the myocardium to the effects of sympathomimetic amines.
• Anesthetics, parenteral-local - Pseudoephedrine should be used cautiously and in carefully circumscribed quantities, if at all, with local anesthetics for anesthetizing areas with end arteries (such as the finger, toes, or penis) or otherwise compromised blood supply; ischemia leading to gangrene may result.
• Anticholinergics - Concurrent use with anticholinergic effects; patients should be advised to report occurrence of gastrointestinal problems promptly since paralytic ileus may occur with concurrent therapy.
• Antidepressants, trycyclic or maprotiline - Concurrent use may potentiate the cardiovascular effects of pseudoephedrine, possible resulting in arrhythmias, tachycardia, or severe hypertension or hyperpyrexia.
• Antihypertensives, or diuretics used as - Antihypertensive effects may be reduced when these medications are used concurrently with pseudoephedrine; the patient should be carefully monitored to confirm that the desired effect is being obtained.
• β-adrenergic blocking agents - Therapeutic effects may be inhibited when these medications are used concurrently with pseudoephedrine, especially larger doses; also, β-adrenergic blockage may result in unopposed α-adrenergic activity with a risk of hypertension and excessive bradycardia with possible heart chlorpheniramine, resulting in headache, cardiac arrhythmias, vomiting or sudden and severe hypertensive and/or hyperpyretic crisis. These medications should not be administered during or within 14 days following the administration of MAO inhibitor therapy.  
• Metoclopramide - Concurrent use of metoclopramide with anticholinergics may antagonize metoclopramide's effects on gastrointestinal motility.
• Potassium chloride - Concurrent use with anticholinergics may increase the severity of potassium chloride-induced gastrointestinal lesions.
• Rauwolfia alkaloids - Concurrent use may prolong the direct-acting sympathomimetic amines by preventing the uptake into storage granules.
  

Laboratory Test Interactions:

Carcinogenesis, Mutagenesis, Impairment of Fertility:

Pregnancy: Category C:

Labor and Delivery:

Nursing Mothers:

Pediatric Use:

Geriatric Use:

ADVERSE REACTIONS:

DRUG ABUSE AND DEPENDENCE

OVERDOSAGE

• Overdosage with sympathomimetic amines can cause cardiac arrhythmias, cerebral hemorrhage and pulmonary edema. It can also cause palpitations, tremor, dizziness, vomiting, fear, labored breathing, headache, dryness of mouth, pallor, weakness, panic, anxiety, confusion, and hallucinations.
• Manifestation of antihistamine overdosage may vary from CNS depression to stimulation. Other signs and symptoms may be dizziness, tinnitus, ataxia, blurred vision, and hypotension. Stimulation is particularly likely in children as are atropine-like signs and symptoms (dry mouth, fixed, dilated pupils, flushing, hypothermia, and gastrointestinal symptoms). In infants and children particularly, antihistamines, in overdosage may produce convulsion and/or death.
• The signs and symptoms of overdosage of anticholinergics are headache, nausea, vomiting, blurred vision, fixed and dilated pupils, hot dry skin, dizziness, dryness of mouth, difficulty in swallowing and CNS stimulation.

• Induction of emesis (syrup of Ipecac recommended); however, precaution against aspiration is necessary, especially in infants and children.
• Gastric lavage (isotonic or 0.45% sodium chloride solution) if patient is unable to vomit within three hours of ingestion.
• Saline Cathartics (milk of magnesia) may be used.
• Vasopressors to treat hypotension; however epinephrine should not be used since it may further lower blood pressure.
• For excessive hypertensive effect an α-adrenergic blocker, such as phentolamine, may be administered.
• Hyperpyrexia, especially in children, may require treatment with tepid water sponge bath.
• Excessive CNS stimulation may be counteracted with parenteral diazepam.
• Oxygen and intravenous fluids.
• Precaution against the use of stimulants (analeptic agents) is recommended because they may cause seizures.
• Excitement to a degree which demands attention may be managed with sodium thiopental 2% solution given slowly intravenously or chloral hydrate (100-200 mL of a 2% solution) by rectal infusion.

DOSAGE AND ADMINISTRATION:

HOW SUPPLIED:

PRODUCT PACKAGING: