Prescription drugs info

Take Buspar exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

Buspar is usually taken for only a short time. Do not take this medication for longer than 4 weeks without your doctors advice.

You may take Buspar with or without food but take it the same way each time.
Some tablet forms of buspirone (Buspar Dividose) may need to be broken before you take the medicine. These tablets have special scored marks on them to make breaking the tablet easy. Do not use the tablet if it has not broken correctly and the piece is too big or too small. Follow your doctors instructions about how much of the tablet to take.

If you have been switched to Buspar from another anxiety medication, you may need to slowly decrease your dose of the other medication rather than stopping suddenly. Some anxiety medications can cause withdrawal symptoms when you stop taking them suddenly after long-term use.
Store Buspar at room temperature away from moisture and heat.

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Do not use Buspar if you are allergic to buspirone, or if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take Buspar before the MAO inhibitor has cleared from your body.

Before taking Buspar, tell your doctor if you are allergic to any drugs, or if you have:

* kidney disease; or
* liver disease.

If you have any of these conditions, you may not be able to use Buspar, or you may need a dosage adjustment or special tests during treatment.

FDA pregnancy category B
This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether Buspar passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not give this medication to a child younger than 18 years old.

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Do not use Buspar if you are allergic to buspirone, or if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take Buspar before the MAO inhibitor has cleared from your body. Buspar can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid drinking alcohol. It may increase some of the side effects caused by Buspar.

Grapefruit and grapefruit juice may interact with Buspar and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor. Do not increase or decrease the amount of grapefruit products in your diet without first talking to your doctor.

Buspar is usually taken for only a short time. Do not take this medication for longer than 4 weeks without your doctors advice.

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Generic Name: buspirone

Buspar is an anti-anxiety medicine that affects chemicals in your brain that may become unbalanced and cause anxiety.

Buspar is used in the treatment of anxiety disorders and and for short-term relief of the symptoms of anxiety, such as fear, tension, irritability, dizziness, pounding heartbeat, and other physical symptoms.

Buspar may also be used for purposes not listed in this medication guide.

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10 mg blue capsules, imprinted Bentyl 10, NDC 58914-012-10: bottles of 100. Store at room temperature, preferably below 86°F (30°C).

20 mg compressed, light blue, round tablets, debossed Bentyl 20, NDC 58914-013-10: bottles of 100. To prevent fading, avoid exposure to direct sunlight. Store at room temperature, preferably below 86°F (30°C).

10 mg/5 mL pink syrup, NDC 58914-015-16: 16 ounce bottle.
Store at room temperature, preferably below 86°F (30°C). Protect from excessive heat.

20 mg/2 mL (10 mg/mL) injection (for intramuscular use only, NOT FOR INTRAVENOUS USE) NDC 58914-080-52: Boxes of five 20 mg/2 mL ampules (10 mg/mL).
Store at room temperature, preferably below 86°F (30°C). Protect from freezing.

Rx only
Rev. March 2005

Bentyl Capsules, Bentyl Tablets and Bentyl Syrup Manufactured by:
Patheon Pharmaceuticals Inc.
Cincinnati, OH 45215

Bentyl Injection Manufactured by:
Akorn Inc.
Decatur, IL 62522
Manufactured for:
Axcan Scandipharm Inc.
Birmingham, AL 35242
www.axcan.com

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DOSAGE MUST BE ADJUSTED TO INDIVIDUAL PATIENT NEEDS.

Adults-Oral . The only oral dose clearly shown to be effective is 160 mg per day (in 4 equally divided doses). Since this dose is associated with a significant incidence of side effects, it is prudent to begin with 80 mg per day (in 4 equally divided doses). Depending upon the patient’s response during the first week of therapy, the dose should be increased to 160 mg per day unless side effects limit dosage escalation. If efficacy is not achieved within 2 weeks or side effects require doses below 80 mg per day, the drug should be discontinued. Documented safety data are not available for doses above 80 mg daily for periods longer than 2 weeks.

Adults-Intramuscular Injection. NOT FOR INTRAVENOUS USE.

The intramuscular dosage form is to be used temporarily when the patient cannot take oral medication. Intramuscular injection is about twice as bioavailable as oral dosage forms; consequently, the recommended intramuscular dose is 80 mg daily (in 4 equally divided doses). Oral dicyclomine hydrochloride should be started as soon as possible and the intramuscular form should not be used for periods longer than 1 or 2 days.

ASPIRATE THE SYRINGE BEFORE INJECTING TO AVOID INTRAVASUCLAR INJECTION, SINCE THROMBOSIS MAY OCCUR IF THE DRUG IS INADVERTENTLY INJECTED INTRAVASCULARLY. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Elderly: In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

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Bentyl overdosage Signs and Symptoms
The signs and symptoms of overdosage are headache; nausea; vomiting; blurred vision; dilated pupils; hot, dry skin; dizziness; dryness of the mouth; difficulty in swallowing; and CNS stimulation. A curare-like action may occur (i.e., neuromuscular blockade leading to muscular weakness and possible paralysis).

A 37-year-old female reported numbness on the left side, cold fingertips, blurred vision, abdominal and flank pain, decreased appetite, dry mouth, and nervousness following ingestion of 320 mg daily (four 20 mg tablets QID) for four days. These events resolved after discontinuing the dicyclomine.

Oral LD50

The acute oral LD50 of the drug is 625 mg/kg in mice.

Bentyl Minimum Human Lethal Dose/Maximum Human Dose Recorded
The amount of drug in a single dose that is ordinarily associated with symptoms of overdosage or that is likely to be life-threatening, has not been defined. The maximum human oral dose recorded was 600 mg by mouth in a 10-month-old child and approximately 1500 mg in an adult, each of whom survived. In three of the infants who died following administration of dicyclomine hydrochloride, the blood concentrations of drug were 200, 220, and 505 ng/mL, respectively.

Bentyl Dialysis
It is not know if Bentyl is dialyzable.

Bentyl Overdosage Treatment
Treatment should consist of gastric lavage, emetics, and activated charcoal. Sedatives (e.g., short-acting barbiturates, benzodiazepines) may be used for management of overt signs of excitement. If indicated, an appropriate parenteral cholinergic agent may be used as an antidote.

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Controlled clinical trials have provided frequency information for reported adverse effects of dicyclomine hydrochloride listed in a decreasing order of frequency.

Not all of the following adverse reactions have been reported with dicyclomine hydrochloride. Adverse reactions are included here that have been reported for pharmacologically similar drugs with anticholinergic/antispasmodic action.

Bentyl Gastrointestinal adverse reactions: dry mouth, nausea, vomiting, constipation, bloated feeling, abdominal pain, taste loss, anorexia

Bentyl Central Nervous System adverse reactions: dizziness, light-headedness, tingling, headache, drowsiness, weakness, nervousness, numbness, mental confusion and/or excitement (especially in elderly persons), dyskinesia, lethargy, syncope, speech disturbance, insomnia

Bentyl Ophthalmologic adverse reactions: blurred vision, diplopia, mydriasis, cycloplegia, increased ocular tension

Bentyl Dermatologic/Allergic adverse reactions: rash, urticaria, itching, and other dermal manifestations; severe allergic reaction or drug idiosyncrasies including anaphylaxis

Bentyl Genitourinary adverse reactions: urinary hesitancy, urinary retention

Bentyl Cardiovascular adverse reactions: tachycardia, palpitations

Bentyl Respiratory adverse reactions: dyspnea, apnea, asphyxia.

Bentyl Other adverse reactions: decreased sweating, nasal stuffiness or congestion, sneezing, throat congestion, impotence, suppression of lactation.

With the injectable form, there may be temporary sensation of light-headedness. Some local irritation and focal coagulation necrosis may occur following the I.M. injection of the drug.

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Clinical studies of Bentyl did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
This drug is known to be substantially excreted by the kidney, 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.

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Bentyl IS CONTRAINDICATED IN INFANTS LESS THAN 6 MONTHS OF AGE.
Safety and effectiveness in pediatric patients have not been established.

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