Sal-Tropine
Prescribing Information

SAL-TROPINE(TM)
Atropine Sulfate, USP
(Oral Use Only)

Description

Atropine is a white, crystalline alkaloid that may be extracted from belladonna root and hyoscyamine or may be produced synthetically. It is used in the form of atropine sulfate because this compound has much greater solubility in water.

Atropine sulfate is an anticholinergic drug. The empirical formula of atropine sulfate is (C17H23NO3)2*H2SO4*H2O, and the molecular weight is 694.84.

SAL-TROPINE is intended for oral use only. Each tablet contains 0.4 mg (0.58 micromol) atropine sulfate. The tablets also contain corn starch, lactose, magnesium stearate, sucrose, and talc.

Clinical Pharmacology

Atropine has 2 main actions. The most important therapeutic action is the inhibition of smooth muscle and glands innervated by postganglionic cholinergic nerves. Atropine also has central-nervous-system activity, which may be either stimulating or depressing depending on the dose.

Following the administration of usual clinical doses (0.5 to 1 mg), atropine produces stimulation of the medulla and higher cerebral centers. This effect is manifested by mild central vagal excitation and moderate respiratory stimulation.

In addition to its effect on the central nervous system, atropine sulfate acts peripherally as a competitive antagonist of the muscarinic actions of acetylcholine. It does not prevent the release of acetylcholine but antagonizes the effect of acetylcholine on the effector cells. These actions include vasodilation; drying of the mouth; increase in pulse rate; inhibition of contractions of the gastrointestinal tract, ureter, and bladder; and reduction of salivary, bronchial, gastric, and sweat gland secretions. Following clinical and larger doses, atropine sulfate causes dilation of the pupils (mydriasis) and paralysis of accommodation (cycloplegia) and, in narrow-angle glaucoma, can increase intraocular pressure.

Indications and Usage

SAL-TROPINE is used to reduce excessive salivation and bronchial secretions.

The antispasmodic action of SAL-TROPINE is useful in pylorospasm and other spastic conditions of the gastrointestinal tract. For ureteral and biliary colic, concomitant use of atropine and morphine may be indicated.

Contraindications

Glaucoma; adhesions (synechiae) between the iris and lens of the eye; asthma.

Precautions

General - Doses of 0.5 to 1 mg of atropine are mildly stimulating to the central nervous system. Larger doses may produce mental disturbances; still larger doses are depressing. Death from atropine poisoning, though rare, is usually due to paralysis of the medullary centers.

Information for Patients - When used in therapeutic doses, atropine can cause dryness of the mouth would be beneficial for excessive salivation. This effect is additive when the product is administered with other drugs that can cause dryness of the mouth.

Patients with prostatism can have difficulty urinating and may require catheterization.

Patients receiving chronic treatment can develop blurred vision and should not be involved in activities that require clear vision.

Drug Interactions - Since atropine sulfate slows gastric emptying and gastrointestinal motility, it may interfere with the absorption of other medications. The potential of atropine to cause mouth dryness may be increased if it is given with other drugs that have anticholinergic action (tricyclic antidepressants, antipsychotics, some antihistamines, and antiparkinsonism drugs). Excessive salivation

Usage in Pregnancy - Pregnancy Category C - Animal reproduction studies have not been conducted with atropine sulfate. It is also not known whether atropine sulfate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Atropine sulfate should be given to a pregnant woman only if clearly needed.

Nursing Mothers - Caution should be exercised when atropine sulfate is administered to a nursing woman. Saltropine reduces excessive salivation

Adverse Reactions

Individual tolerance varies greatly, but these systemic doses are likely to produce the following effects:

0.5 mg - Slight dryness of nose and mouth; bradycardia.

1 mg - Greater dryness of nose and mouth with thirst; slowing, then acceleration of heart; slight mydriasis.

2 mg - Very dry mouth; tachycardia with palpitations; mydriasis, slight blurring of near vision; flushed, dry skin.

5 mg - Increase in above symptoms plus disturbance of speech; difficulty in swallowing; headache; hot, dry skin; restlessness with asthenia.

10 mg and over - Above symptoms to extreme degree plus ataxia, excitement, disorientation, hallucinations, delirium, and coma.

A scarlatiniform rash may occur. Atropine may produce fever, particularly in children, through inhibition of heat loss by evaporation. Although large doses of atropine may cause an alarming condition, recovery is usual.

Overdosage

Signs and Symptoms - Symptoms of atropine overdose include mydriasis, tachycardia, decreased salivation and sweating, diminished bowel sounds, urinary retention, hypertension, and vasodilation. CNS symptoms include anxiety, disorientation, hallucinations, hyperactivity, and convulsions or coma. Hyperthermia may occur.

Treatment - To obtain up-to-date information about the treatment of overdose, a good resource is your certified Regional Poison Control Center. Telephone numbers of certified poison control centers are listed in the Physicians' Desk Reference (PDR). In managing overdosage, consider the possibility of multiple drug overdoses, interaction among drugs, and unusual drug kinetics in your patient.

The fatal dose of atropine in children may be as low as 10 mg. In an adult, a dose of 10 mg usually produces severe distress, but recovery after 1,000 mg has been reported. Information is scant on serum concentrations that may be toxic or lethal. The oral median lethal dose in rats is 622 mg/kg.

Protect the patient's airway and support ventilation and perfusion. Meticulously monitor and maintain, within acceptable limits, the patients vital signs, blood gases, serum electrolytes, etc. Absorption of drugs from the gastrointestinal tract may be decreased by giving activated charcoal, which, in many cases, is more effective than emesis or lavage; consider charcoal instead of or in addition to gastric emptying. Repeated doses of charcoal over time may hasten elimination of some drugs that have been absorbed. Safeguard the patient's airway when employing gastric emptying or charcoal.

Physostigmine may reverse some of the effects of atropine overdose in some patients, but it should be used cautiously while closely monitoring and supporting the patient's airway, ventilation, and cardiac rhythm. Cholinergic toxicity from physostigmine may include bronchospasm, bronchorrhea, bradycardia, asystole, diaphoresis, incontinence, and seizures. If used, give physostigmine slowly because rapid injection may cause seizures. The effects of physostigmine may be short-lived and repeated doses may be necessary for continued improvement.

Forced diuresis, peritoneal dialysis, hemodialysis, or charcoal hemoperfusion have not been established as beneficial for an overdose of atropine.

Dosage and Administration

The usual oral adult dose of atropine is 0.4 mg.
Suggested doses for children are as follows:

7-16 pounds - 0.1 mg
17-24 pounds - 0.15 mg
24-40 pounds - 0.2 mg
40-65 pounds - 0.3 mg
65-90 pounds - 0.4 mg
Over 90 pounds - 0.4 mg

These doses may be exceeded in certain cases.

How Supplied

SAL-TROPINE(TM) Tablets
Atropine Sulfate, USP
0.4 mg per tablet
Packaged in Bottles of 100
NDC 60267-742-30

Tablet Identification - White, imprinted "HOPE", "742"

Rx Only.