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MISTOL

Generic Name

Misoprostol

Therapeutic class

Anti-ulcer

Pharmacological Class

Prostaglandin analogue

Composition

Each uncoated tablet of Mistol 200, Mistol 100 and Mistol 50 contain 200 mcg, 100 mcg and 50 mcg Misoprostol.

Pregnancy category

‘X’

Presentation

Mistol 200:

Available in the pack size as 4 tablets X 1 blister

Mistol 100 and Mistol 50:

Available in the pack size as 10 tablets X10 blisters.

What is Mistol?

Mistol, available as 200 mcg, 100 mcg and 50 mcg tablets, contains Misoprostol, which is used to reduce the risk of NSAID related ulcers, manage miscarriages, prevent post partum hemorrhage, and also for medical termination of pregnancy.

In what conditions Mistol can be used?

·       Incomplete Abortion

·       Missed Abortion

·       In combination with mifepristone it can be used for medical termination of pregnancy.

·       For protection of the lining of the stomach from NSAID-induced ulcers

                             

How does Mistol work?          
Misoprostol is a prostaglandin analog; the stimulation of prostaglandin receptors in the stomach reduces gastric acid secretion, while stimulating these receptors in the uterus and
cervix can increase the strength and frequency of contractions and decrease cervical tone. 

How to take Mistol?    

Route of administration: Vaginally, orally, bucally 400 mcg or 800 mcg. (Smaller dose while given vaginally.)

 

1.   Pregnancy Termination (0-12 weeks): 800 mcg of Mistol orally/vaginally/buccally administered within 48 hours following mifeprostone (Pregno) administration.

2.   Missed abortion (0-12 weeks): In the absence of vaginal bleeding, 800mcg vaginally every three hours until pregnancy expulsion (generally 1-3 doses).

3.   Incomplete abortion (0-12 weeks): 600 mcg buccally/orally or 400mcg vaginally in the absence of vaginal bleeding.

4.  Postpartum Hemorrhage

                                                            i.      Prophylaxis: 600 mcg orally within 1 minute of delivery

                                                         ii.      Treatment: 800 mcg orally once; use caution if prophylactic dose already given and adverse effects present or observed

 

 5. Induction of Labor

Vaginal low-dose misoprostol (25 mcg, 6-hourly) is       recommended for induction of labour.

Not to be used in patients with previous cesarean delivery or major uterine surgery.

 

6.  Stress Ulcer Prophylaxis

100-200 mcg orally every 4-6hr

 

7.  NSAID-Induced Ulcer

Prophylaxis: 200 mcg orally every 6hr with food; may be decreased to 100 mcg every 6hr if higher dose is not tolerated; last dose to be administered at bedtime.

                                                       

Take Mistol exactly as directed by your healthcare provider. Do not take more or less of it or take it more often or for a longer period of time than prescribed by your doctor.

                                                                                          

What to do if a dose is missed?

 

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

                                                                           

What do you need to know before you take Mistol?          

Tell your healthcare provider:

·        If you are allergic to any component of the formulation.

·       If you are getting oxytocin

·       About all of your drugs (prescription or OTC, natural products, vitamins).

 

Do not hesitate to provide information to your healthcare provider about the underlying health conditions that you have and also about other medicines that you are currently taking.

                                                                        

Warnings and Precautions:

·       Do not take mistol to prevent ulcers if you are pregnant or plan to become pregnant. Mistol may cause miscarriages, premature labor, or birth defects.

·       If you are a woman of childbearing age, you may take mistol to prevent ulcers only if you have had a negative pregnancy test in the past 2 weeks and if you use a reliable method of birth control while taking mistol. You must begin taking misoprostol on the second or third day of your menstrual period. If you become pregnant while taking mistol, stop taking it and call your doctor immediately.

·       Do not let anyone else take your medication, especially a woman who is or may become pregnant.

·       Mistol is a very powerful stimulator of uterine contractions in late pregnancy and can cause fetal death and uterine rupture if used in high doses. Follow the dosage regimens carefully and do not exceed those doses.

 

 Can Mistol be taken during pregnancy?

Use of Mistol is contraindicated in case of wanted pregnancies.

          

Can lactating mothers consume Mistol?  

Mistol passes into breast milk. However, it is unlikely to harm a nursing infant. Consult with your healthcare provider before breast-feeding.                                             


Should Mistol be taken with or without food?

                                                                                       

Take Mistol with food. Food decreases incidence of diarrhea particularly when it is used for protection of the lining of the stomach from NSAID-induced ulcers.

                                                   

Possible Side effects:             

Mistol may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away

·       diarrhea

·       headache

·       stomach pain

·       upset stomach

·       gas

·       vomiting

·       constipation

·       indigestion

If you experience any of the following symptoms, call your doctor immediately:

·       vomiting blood

bloody or black, tarry stools

Pharmacodynamics:
Misoprostol is a prostaglandin E1 analog used to reduce the risk of NSAID induced gastric ulcers by reducing secretion of gastric acid from parietal cells. 
Being a synthetic prostaglandin E1 analog, it stimulates prostaglandin E1 receptors on parietal cells in the stomach to reduce gastric acid secretion. Mucus and bicarbonate secretion are also increased along with thickening of the mucosal bilayer, so the mucosa can generate new cells.

Misoprostol is also used to manage miscarriages and used alone or in combination with mifepristone for first trimester abortions.  Misoprostol binds to smooth muscle cells in the uterine lining to increase the strength and frequency of contractions as well as degrade collagen and reduce cervical tone.

 

Pharmacokinetics:

Absorption:  Rapid absorption 

Volume of distribution: Data regarding the volume of distribution of misoprostol is scarce.

Protein binding: Approximately 85%      

Metabolism: Hepatic                  

Route of elimination: Urine

Half-life: The half life of elimination is 20-40 minutes. 

OUR PRODUCTS

For the use of a registered medical practitioner or a hospital or a laboratory only*  

Misoprostol Tablets IP 50/100/200 mcg

MISTOL

COMPOSITION

Mistol-50:

Each uncoated tablet contains

Misoprostol                             50 mcg

(1% dispersion in HPMC)

Mistol-100:

Each uncoated tablet contains

Misoprostol                             100 mcg

(1% dispersion in HPMC)

Mistol:   

Each uncoated tablet contains

Misoprostol                             200 mcg

(1% dispersion in HPMC)

PHARMACOLOGY

Pharmacodynamics

Mistol contains Misoprostol which is a synthetic prostaglandin E1. Prostaglandin E1 causes myometrial contractions by interacting with specific receptors on myometrial cells. The interactions result a change in calcium concentration, thereby initiating muscle contractions. Misoprostol causes softening of the cervix, promotes enhanced dilation facilitating intra-uterine procedures as well as expulsion of the contents of the uterus.

Pharmacokinetics

Misoprostol is extensively absorbed and undergoes rapid de-esterification to its free acid, which is responsible for its clinical activity and, unlike the parent compound, is detectable in plasma. The alpha side chain undergoes beta oxidation and the beta side chain undergoes omega oxidation followed by reduction of the ketone to give prostaglandin F analogs. After oral administration, the plasma concentration increases rapidly to a peak at 30 minutes and then declines rapidly by 120 minutes. The free acid form is highly protein bound. The metabolites undergo biphasic elimination, where the first phase lasts for 1.5 hours while the slow phase extends from 144 to 177 hours.

INDICATIONS

  • Medical Termination of Pregnancy in first trimester
  • Cervical Ripening
  • Prevention of postpartum hemorrhage
  • Gastrointestinal use

DOSAGE AND METHOD OF ADMINISTRATION

  1. Cervical ripening

Cervical ripening for induction of labor (live baby > 28 weeks)

50 mcg MISTOL vaginally, every 6 hours


Cervical ripening for induction of labor (intrauterine fetal death> 28 weeks)

50 mcg MISTOL vaginally, every 3-4 hours until delivery; maximum six doses


Cervical ripening prior to uterine instrumentation

400 mcg MISTOL, 2-3 hours before the procedure

  • Prevention of postpartum hemorrhage

600 mcg MISTOL orally immediately after cord clamping

  • Medical Termination of Pregnancy

400 mcg MISTOL orally after 24-48 hours of Mifepristone administration

  • Gastrointestinal use

The recommended adult oral dose for reducing NSAID-induced ulceration is 200 mcg four times daily with food.

CONTRAINDICATIONS

Known hypersensitivity to misoprostol or other prostaglandins

WARNING AND PRECAUTIONS

Obstetric and Gynecological uses

  • During the period immediately following the administration of Misoprostol, the patient may need medication for cramps or gastrointestinal symptom. The patient should be provided with necessary instructions.
  • Any Intra Uterine Device (IUD) should be removed before treatment with Mifepristone begins. Pregnancy termination by surgery is recommended in case when Mifepristone and Misoprostol fail to terminate pregnancy.
  • Patient who have ongoing pregnancy at last visit have a risk of fetal malformation resulting from the treatment. Surgical termination is recommended to manage medical abortion treatment failures.

Anti-ulcer use

  • Do not take Misoprostol to prevent ulcers if you are pregnant or plan to become pregnant. Misoprostol may cause miscarriages, premature labor, or birth defects.

DRUG INTERACTIONS

Misoprostol has been shown to interfere with the beneficial effects of aspirin or signs and symptoms of rheumatoid arthritis. Misoprostol does not exert clinically significant effects on absorption, blood levels and anti-platelet effects of therapeutic doses of aspirin. Misoprostol has no clinically significant effect on the kinetics of diclofenac or ibuprofen. The most common side effect of misoprostol is diarrhea and abdominal pain. These side effects may be increased if misoprostol is taken concurrently with antacids.

SIDE EFFECTS

General

  • Gastro-intestinal side effects like diarrhea, abdominal pain, nausea, flatulence, dyspepsia, headache, vomiting and constipation
  • Shivering
  • Hyperthermia
  • Dizziness

For Obstetrics and Gynecology Use

  • Patient may experience pain due to uterine contractions
  • Severe genital bleeding
  • Shock
  • Pelvic Pain
  • Uterine rupture (requiring surgical repair, hysterectomy, and/or salpingo-oophorectomy)

OVERDOSE

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 fatty acid, it is unlikely that dialysis would be appropriate treatment for overdose.

Storage and Handling Instructions

Store in a cool, dry place, out of reach of children.

PRESENTATION

Mistol 50 and Mistol 100 are available in the pack of 10’s in ALU-ALU blister. 10 such blisters are packed in a printed carton.

Mistol is available in the pack of 4’s in ALU-ALU blister. 1 such blister is packed in a printed carton.

Ref:

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Manufactured by

Ohm Pharmaceuticals Labs. (P) Ltd.

Tathali-9, Bhaktapur, Nepal

A WHO: GMP certified company

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