Levsin SL

Name: Levsin SL

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What other drugs will affect Levsin SL (hyoscyamine)?

Tell your doctor about all other medicines you use, especially:

  • amantadine (Symmetrel);

  • haloperidol (Haldol);

  • an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate);

  • phenothiazines such as chlorpromazine (Thorazine), fluphenazine (Permitil, Prolixin), perphenazine (Trilafon), prochlorperazine (Compazine, Compro), promethazine (Pentazine, Phenergan, Anergan, Antinaus), thioridazine (Mellaril), or trifluoperazine (Stelazine); or

  • an antidepressant such as amitriptyline (Elavil, Vanatrip), doxepin (Sinequan), desipramine (Norpramin), imipramine (Janimine, Tofranil), nortriptyline (Pamelor), and others.

This list is not complete and other drugs may interact with hyoscyamine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Levsin®/SLtablets (hyoscyamine sulfate tablets USP)

Rx only

500364     113     Rev. 02/08

Levsin SL - Clinical Pharmacology

Levsin®/SL inhibits specifically the actions of acetylcholine on structures innervated by postganglionic cholinergic nerves and on smooth muscles that respond to acetylcholine but lack cholinergic innervation. These peripheral cholinergic receptors are present in the autonomic effector cells of the smooth muscle, cardiac muscle, the sinoatrial node, the atrioventricular node, and the exocrine glands. At therapeutic doses, it is completely devoid of any action on autonomic ganglia. Levsin®/SL inhibits gastrointestinal propulsive motility and decreases gastric acid secretion. Levsin®/SL also controls excessive pharyngeal, tracheal and bronchial secretions.

Levsin®/SL is absorbed totally and completely by sublingual administration as well as oral administration. Once absorbed, Levsin®/SL disappears rapidly from the blood and is distributed throughout the entire body. The half-life of Levsin®/SL is 2 to 3½ hours. Levsin®/SL is partly hydrolyzed to tropic acid and tropine but the majority of the drug is excreted in the urine unchanged within the first 12 hours. Only traces of this drug are found in breast milk. Levsin®/SL passes the blood brain barrier and the placental barrier. The tablets can be taken orally with the same pharmacological effects occurring; however, the effects may not occur as rapidly as with sublingual administration.

How supplied

Levsin®/SL tablets (hyoscyamine sulfate tablets USP) 0.125 mg are round, blue colored tablets that are imprinted with “AP” on one side and “113” on the other.

Bottles of 100 tablets          NDC 68220-113-10
Bottles of 500 tablets          NDC 68220-113-50

Store at controlled room temperature 20°- 25°C (68° - 77°F); excursions permitted to 15°- 30°C (59°- 86°F). Please refer to current USP.

Dispense in tight, light-resistant containers as defined in USP/NF with a child-resistant closure.

KEEP OUT OF REACH OF CHILDREN

Also available as:

Levsin®    Dosage
   Strength
Package
Size
NDC
Tablets    0.125mg 100 68220-112-10
Tablets    0.125mg 500 68220-112-50
Sub-lingual Tablets    0.125mg 100 68220-113-10
Sub-lingual Tablets    0.125mg 500 68220-113-50
Elixir    0.125mg/5 mL Pint 0091-4532-16
Drops    0.125mg/mL 15mL 0091-4538-15
Injection    0.5mg/mL Box of 5-1mL 0091-1536-05
Levbid® extended-    0.375mg 100 68220-115-10
release tablets    0.375mg 500 68220-115-50

Manufactured for:

ALAVEN® PHARMACEUTICAL LLC

Marietta, GA 30067

Address medical inquiries to:
Alaven Pharmaceutical LLC
2260 Northwest Parkway, Suite A
Marietta, GA 30067

Or call toll free 1-888-317-0001

Package Label – Principal Display Panel - 100-count Bottle, 0.125 mg Tablets

NDC 68220-113-10

Levsin®/SL tablets

(hyoscyamine sulfate tablets USP)

0.125 mg

sublingual / chewable / oral

Rx only

ALAVEN® PHARMACEUTICAL LLC 100 tablets

For medical inquiries call 1-888-317-0001

LEVSIN   SL
hyoscyamine sulfate tablet, orally disintegrating
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:68220-113
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYOSCYAMINE SULFATE (HYOSCYAMINE) HYOSCYAMINE SULFATE 0.125 mg
Product Characteristics
Color BLUE Score no score
Shape ROUND Size 8mm
Flavor Imprint Code AP;113
Contains     
Packaging
# Item Code Package Description
1 NDC:68220-113-10 100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE
2 NDC:68220-113-50 500 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved Drug Other 12/01/2008
Labeler - Alaven Pharmaceutical LLC (140210829)
Revised: 05/2013   Alaven Pharmaceutical LLC

What are some things I need to know or do while I take Levsin/SL?

  • Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
  • Avoid driving and doing other tasks or actions that call for you to be alert or have clear eyesight until you see how Levsin/SL affects you.
  • Talk with your doctor before you drink alcohol or use other drugs and natural products that slow your actions.
  • Be careful in hot weather or while being active. Drink lots of fluids to stop fluid loss.
  • Good mouth care, sucking hard, sugar-free candy, or chewing sugar-free gum may help with dry mouth. See a dentist often.
  • If you are 65 or older, use this medicine with care. You could have more side effects.
  • Different brands of Levsin/SL may be for use in different ages of children. Talk with the doctor before giving this medicine to a child.
  • Use with care in children. Talk with the doctor.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Levsin/SL while you are pregnant.

How do I store and/or throw out Levsin/SL?

  • Store at room temperature.
  • Store in a dry place. Do not store in a bathroom.
  • Protect from light.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Check with your pharmacist about how to throw out unused drugs.

Consumer Information Use and Disclaimer

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else's drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take Levsin/SL or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Levsin/SL. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

For the Consumer

Applies to hyoscyamine: oral conventional tablets and sublingual tablets, oral extended-release capsules and tablets, oral oral solution and elixir, oral orally disintegrating tablets, parenteral injection

Side effects include:

Most adverse effects are manifestations of pharmacologic effects at muscarinic-cholinergic receptors and usually are reversible when therapy is discontinued.

Severity and frequency of adverse effects are dose related and individual intolerance varies greatly; adverse effects occasionally may be obviated by a reduction in dosage but this also may eliminate potential therapeutic effects.

Adverse effects include dry mouth, urinary hesitancy and retention, blurred vision, tachycardia, palpitations, mydriasis, increased ocular tension, loss of taste, headache, nervousness, drowsiness, weakness, fatigue, dizziness, insomnia, nausea, vomiting, impotence, constipation, bloated feeling, abdominal pain, diarrhea, allergic reactions or drug idiosyncrasies, urticaria and other dermal manifestations, ataxia, speech disturbance, mental confusion and/or excitement (especially in geriatric patients), short-term memory loss, hallucinations, and decreased sweating.

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