Misoprostol (Page 4 of 4)

OVERDOSAGE

The toxic dose of Misoprostol Tablets in humans has not been determined. Cumulative total daily doses of 1600 mcg have been tolerated, with only symptoms of gastrointestinal discomfort being reported. In animals, the acute toxic effects are diarrhea, gastrointestinal lesions, focal cardiac necrosis, hepatic necrosis, renal tubular necrosis, testicular atrophy, respiratory difficulties, and depression of the central nervous system. Clinical signs that may indicate an overdose are sedation, tremor, convulsions, dyspnea, abdominal pain, diarrhea, fever, palpitations, hypotension, or bradycardia. Symptoms should be treated with supportive therapy.

It is not known if misoprostol acid is dialyzable. However, because misoprostol is metabolized like a fatty acid, it is unlikely that dialysis would be appropriate treatment for overdosage.

DOSAGE AND ADMINISTRATION

The recommended adult oral dose of Misoprostol Tablets for reducing the risk of NSAID-induced gastric ulcers is 200 mcg four times daily with food. If this dose cannot be tolerated, a dose of 100 mcg can be used. (See Clinical Pharmacology: Clinical studies.) Misoprostol Tablets should be taken for the duration of NSAID therapy as prescribed by the physician. Misoprostol Tablets should be taken with a meal, and the last dose of the day should be at bedtime.

Renal impairment

Adjustment of the dosing schedule in renally impaired patients is not routinely needed, but dosage can be reduced if the 200-mcg dose is not tolerated. (See Clinical Pharmacology.)

HOW SUPPLIED

Product: 50436-3172

NDC: 50436-3172-1 4 TABLET in a BOTTLE

NDC: 50436-3172-3 9 TABLET in a BOTTLE

NDC: 50436-3172-4 8 TABLET in a BOTTLE

NDC: 50436-3172-2 3 TABLET in a BOTTLE

PATIENT INFORMATION

Read this leaflet before taking Misoprostol Tablets and each time your prescription is renewed, because the leaflet may be changed.

Misoprostol Tablets is being prescribed by your doctor to decrease the chance of getting stomach ulcers related to the arthritis/pain medication that you take.

Do not take Misoprostol Tablets to reduce the risk of NSAID-induced ulcers if you are pregnant. (See boxed WARNINGS.) Misoprostol Tablets can cause abortion (sometimes incomplete which could lead to dangerous bleeding and require hospitalization and surgery), premature birth, or birth defects. It is also important to avoid pregnancy while taking this medication and for at least one month or through one menstrual cycle after you stop taking it. Misoprostol Tablets has been reported to cause the uterus to rupture (tear) when given after the eighth week of pregnancy. Rupture (tearing) of the uterus can result in severe bleeding, hysterectomy, and/or maternal or fetal death.

If you become pregnant during Misoprostol Tablets therapy, stop taking Misoprostol Tablets and contact your physician immediately. Remember that even if you are on a means of birth control it is still possible to become pregnant. Should this occur, stop taking Misoprostol Tablets and contact your physician immediately.

Misoprostol Tablets may cause diarrhea, abdominal cramping, and/or nausea in some people. In most cases these problems develop during the first few weeks of therapy and stop after about a week. You can minimize possible diarrhea by making sure you take Misoprostol Tablets with food.

Because these side effects are usually mild to moderate and usually go away in a matter of days, most patients can continue to take Misoprostol Tablets. If you have prolonged difficulty (more than 8 days), or if you have severe diarrhea, cramping and/or nausea, call your doctor.

Take Misoprostol Tablets only according to the directions given by your physician.

Do not give Misoprostol Tablets to anyone else. It has been prescribed for your specific condition, may not be the correct treatment for another person, and would be dangerous if the other person were pregnant.

This information sheet does not cover all possible side effects of Misoprostol Tablets. This patient information leaflet does not address the side effects of your arthritis/pain medication. See your doctor if you have questions.

Keep out of reach of children.

Rx only
September 2012

Manufactured by:
Novel Laboratories, Inc.
Somerset, NJ 08873

PI1600003501

MISOPROSTOL TABLET

Label Image
(click image for full-size original)
MISOPROSTOL
misoprostol tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50436-3172(NDC:63704-008)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MISOPROSTOL (MISOPROSTOL) MISOPROSTOL 200 ug
Inactive Ingredients
Ingredient Name Strength
Hydrogenated Castor Oil
MICROCRYSTALLINE CELLULOSE
CROSPOVIDONE (15 MPA.S AT 5%)
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 9mm
Flavor Imprint Code 161;n
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50436-3172-1 4 TABLET in 1 BOTTLE None
2 NDC:50436-3172-3 9 TABLET in 1 BOTTLE None
3 NDC:50436-3172-4 8 TABLET in 1 BOTTLE None
4 NDC:50436-3172-2 3 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091667 04/12/2013
Labeler — Unit Dose Services (831995316)
Establishment
Name Address ID/FEI Operations
Unit Dose Services 831995316 REPACK (50436-3172), RELABEL (50436-3172)

Revised: 03/2018 Unit Dose Services

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