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TECTOR (Misoprostol Tablets)

TECTOR (Misoprostol Tablets)
TECTOR (Misoprostol Tablets)
Product Code : 14
Brand Name : TECTOR
Product Description

TECTOR

Misoprostol Tablets

 

COMPOSITION

Each uncoated tablet contains

Misoprostol ............. 200 mcg

 

DOSAGE FORM

Tablets for oral/vaginal use

 

DESCRIPTION

Misoprostol is a synthetic prostaglandin E 1 . Misoprostol causes the cervix to soften and the uterus to contract and also inhibits gastric acid secretion in humans.

 

PHARMACOLOGY

 

Pharmacodynamics

Prostaglandin E 1 causes myometrial contractions by interacting with specific receptors on myometrial cells. This interaction results in a change in calcium concentration, thereby initiating muscle contraction. By nteracting with prostaglandin receptors, misoprostol causes the cervix to soften and the uterus to contract, resulting in the expulsion of the uterine contents.

 

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. The compound is a lipophilic methyl ester prodrug and is readily metabolized to the free acid, which is the biologically active form. Following oral administration, the plasma misoprostol levels increased rapidly, with a peak at 30 minutes, declined rapidly by 120 minutes, and remained low thereafter.

 

In contrast, after vaginal administration, the plasma concentration gradually increased, reaching maximum levels after 70-80 minutes and slowly declined with detectable levels present after 6 hours. Vaginal misoprostol was present in the circulation longer than oral misoprostol and hence its  duration of stimulation of the uterus exceeds that of oral misoprostol. When misoprostol is administered vaginally plasma concentrations of misoprostol acid peak in one to two hours and then decline slowly. Vaginal application of misoprostol results in slower increases and lower peak plasma concentrations of misoprostol acid than does oral administration, but overall exposure to the drug is increased.

 

INDICATIONS

Obstetrics and Gynaecology use

 

First trimester abortion

TECTOR with mifepristone is indicated for the medical termination of intrauterine pregnancy through 49 days pregnancy. For this purpose, pregnancy is dated from the first day of the last menstrual period in a presumed 28 days cycle with ovulation occurring at mid-cycle.

 

Cervical ripening

Cervical ripening prior to uterine instrumentation

Cervical ripening for induction of labour in live foetus and intrauterine foetal death

 

Prevention of post-partum haemorrhage

 

 

DOSAGE AND ADMINISTRATION

 

For Medical Abortion

Mifepristone (RELEZED Tablet) is administered prior to misoprostol (TECTOR). Treatment with mifepristone and TECTOR for the termination of pregnancy requires three clinic visits by the patient. Mifepristone may be administered only in a clinic or hospital, by or under the supervision of a gynaecologist, able to assess the gestational age of an embryo and to diagnose ectopic pregnancies. The gynaecologist must also be able to provide surgical intervention in cases of incomplete abortion or severe bleeding, or have made plans to provide such care through others, and be able to assure the patient access to medical facilities equipped to provide blood transfusions and resuscitation, if necessary.

 

Day One: Mifepristone (RELEZED) administration

Three 200 mg tablets (600 mg) of mifepristone are taken in a single oral dose.

 

Day Three: TECTOR administration

The patient returns to the healthcare provider two days after ingesting mifepristone. Unless abortion has occurred and has been confirmed by clinical examination or ultrasonographic scan, the patient takes two 200 mcg tablets (400 mcg) of TECTOR orally. During the period immediately following the administration of misoprostol, the patient may need medication for cramps or gastrointestinal symptoms. The patient should be given instructions on what to do if significant discomfort, excessive bleeding or other adverse reactions occur and should be given a phone number to call if she has questions following the administration of the TECTOR.

 

Day 14 : Post-Treatment Examination

The patient will return for a follow-up visit approximately 14 days after the administration of mifepristone. This visit is very important to confirm by clinical examination or ultrasonographic scan that a complete termination of pregnancy has occurred. Patients who have an ongoing pregnancy at this visit have a risk of foetal malformation resulting from the treatment. Surgical termination is recommended to manage medical abortion treatment failures.

 

For Cervical Ripening

·          Cervical ripening prior to uterine instrumentation

Dosage: 400 μg TECTOR vaginally, 2-3 hours before the procedure.

 

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

Dosage: 25 μg TECTOR vaginally, every 3-4 hours until contractions.

 

Maximum: Six doses

 

Should be used in institutions that are able to perform caesarean sections. Foetal well-being and

uterine contractions should be monitored. Beware of uterine hyperstimulation with the risk of uterine

rupture and foetal distress.

 

·          Cervical ripening for induction of labour (intrauterine foetal death >28 weeks)

Dosage: 50 μg TECTOR vaginally, every 3-4 hours until delivery.

Maximum: Six doses

 

For Prevention of Post Partum Haemorrhage

600 μg TECTOR orally immediately after cord clamping.

 

 

CONTRAINDICATIONS

·           Known hypersensitivity to misoprostol or other prostaglandins.

For Obstetrics and Gynaecology use

For medical abortion

 

Administration of mifepristone and misoprostol for the termination of pregnancy is contraindicated in

patients with any one of the following conditions:

 

·          Confirmed or suspected ectopic pregnancy or undiagnosed adnexal mass (the treatmentprocedure will not be effective to terminate an ectopic pregnancy)

·          IUD in place

·          Chronic adrenal failure

·          History of allergy to mifepristone, misoprostol or other prostaglandin

·          Haemorrhagic disorders or concurrent anticoagulant therapy

·          Inherited porphyria

·          If a patient does not have adequate access to medical facilities equipped to provide emergency treatment of incomplete abortion, blood transfusions, and emergency resuscitation during the period from the first visit until discharged by the administering physician.

 

Cervical ripening


·          Severe bronchial asthma or active cardiac disease

·          Cephalo pelvic disproportion

·          Placenta previa

·          Malpresentations

·          Previous caesarean section

·          Previous uterine surgery

·          Acute foetal distress

·          Abruptio placenta

·          Unexplained vaginal bleeding.


 

WARNINGS AND PRECAUTIONS

General

The patient should not give TECTOR to anyone else.

 

·          TECTOR has been prescribed for the patient`s specific condition, it may not be the correct treatment for another person, and may be dangerous to the other person if she is or were to become pregnant.

·          Some authors suggest moistening misoprostol with 3-4 drops of saline /distilled water when used for vaginal administration.

 

When used for Medical Abortion

·          During the period immediately following the administration of misoprostol, the patient may need medication for cramps or gastrointestinal symptoms. The patient should be given instructions on what to do if significant discomfort, excessive bleeding or other adverse reactions occur and should be given a phone number to call if she has questions following the administration of TECTOR .

·          Any intrauterine device [“IUDâ€�] should be removed before treatment with mifepristone begins. Pregnancy termination by surgery is recommended in cases when mifepristone and misoprostol fail to cause termination of intrauterine pregnancy.

·          Patients who have an ongoing pregnancy at last visit have a risk of foetal malformation resulting from the treatment. Surgical termination is recommended to manage medical abortion treatment failures.

 

When used for cervical ripening for induction of labour

·          When used for cervical ripening for a pregnant woman with live foetus it is important that TECTOR should be used in institutions that are able to perform caesarean sections.

·          Foetal well being and uterine contractions should be monitored. Beware of uterine hyperstimulation with the risk of uterine rupture and foetal distress. Continuous monitoring of uterine contractions and foetal heart sounds should be done to rule out uterine hyperstimulation, foetal distress and meconium stained liquor.

·          Oxytocin should not be used for 6 hrs after the administration of the last dose of misoprostol as it may lead to hyperstimulation of the uterus.

·          The risk factors for uterine rupture include later trimester pregnancies, larger doses of the drug, prior caesarean section or uterine surgery, and a history of five or more previous pregnancies. This information may allow physicians to better identify patients at risk and thereby improve the safe use of misoprostol.

·          The patient should be examined prior to the administration of TECTOR. The foetus should be in vertex presentation.

·          Multifoetal pregnancies are not excluded as long as the leading foetus is vertex.

·          Misoprostol can be used with intact or ruptured membranes.

·          There may be an increased risk of uterine tachysystole, uterine rupture, meconium passage, meconium staining of amniotic fluid, and caesarean delivery due to uterine hyperstimulation with the use of higher doses of misoprostol .

 

For prevention of Post-Partum Haemorrhage

 

TECTOR should be administered orally immediately after cord clamping.

 

 

 

Drug interactions

 

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

 

Renal impairment

Pharmacokinetic studies in patients with varying degrees of renal impairment showed an approximate doubling of T 1/2 , C max , and AUC compared to normal, but no clear correlation between the degree of impairment and AUC. In subjects over 64 years of age, the AUC for misoprostol acid is increased. No routine dosage adjustment is recommended in older patients or patients with renal impairment, but dosage may need to be reduced if the usual dose is not tolerated.

 

Hepatic impairment

Patients with hepatic disease should receive a decreased dose.

 

Pregnancy

When mifepristone and TECTOR are used for abortion (upto 49 days)Patients who have an ongoing pregnancy at the last visit have a risk of foetal malformation resulting from the treatment. Surgical termination is recommended to manage medical abortion treatment failures.

 

When used for cervical ripening for labour and delivery

There may be an increased risk of uterine tachysystole, uterine rupture, meconium passage, meconium staining of amniotic fluid and caesarean delivery due to uterine hyperstimulation with the use of higher doses of misoprostol . The risk of uterine rupture increases with advancing gestational ages and with prior uterine surgery, including caesarean delivery. Grand multiparity also appears to be a risk factor for uterine rupture.

 

Lactation

Although it is not known whether misoprostol or misoprostol acid is excreted in human milk, TECTOR should not be administered to nursing mothers because the potential excretion of misoprostol acid could cause diarrhoea in nursing infants.

 

Paediatric use

Safety and effectiveness of misoprostol in paediatric patients have not been established.

 

UNDESIRABLE EFFECTS

General


·          Gastro-intestinal side effects like diarrhoea, abdominal pain, nausea, flatulence, dyspepsia, headache, vomiting and constipation

·          Shivering

·          Hyperthermia

·          Dizziness


 

Incidence greater than 1%

In clinical trials, the following adverse reactions were reported by more than 1% of the subjects receiving misoprostol and may be causally related to the drug: nausea (3.2%), flatulence (2.9%), headache (2.4%), dyspepsia (2.0%), vomiting (1.3%), and constipation (1.1%). However, there were no significant differences between the incidences of these events for misoprostol and placebo.

 

Causal relationship unknown

The following adverse events were infrequently reported. Causal relationships between misoprostol

and these events have not been established but cannot be excluded:

 

Body as a whole : aches/pains, asthenia, fatigue, fever, rigors, weight changes.

Skin : rash, dermatitis, alopecia, pallor, breast pain.

Special senses : abnormal taste, abnormal vision, conjunctivitis, deafness, tinnitus, earache. Respiratory : upper respiratory tract infection, bronchitis, bronchospasm, dyspnea, pneumonia, epistaxis.

Cardiovascular : chest pain, oedema, diaphoresis, hypotension, hypertension, arrhythmia, phlebitis, increased cardiac enzymes, syncope.

Gastrointestinal : GI bleeding, GI inflammation/infection, rectal disorder, abnormal hepatobiliary function, gingivitis, reflux, dysphagia, amylase increase.

Hypersensitivity : anaphylaxis

Metabolic : glycosuria, gout, increased nitrogen, increased alkaline phosphatase.

Genitourinary : polyuria, dysuria, haematuria, urinary tract infection.

Nervous system/Psychiatric : anxiety, change in appetite, depression, drowsiness, dizziness, thirst, impotence, loss of libido, sweating increase, neuropathy, neurosis, confusion.

Musculoskeletal : arthralgia, myalgia, muscle cramps, stiffness, back pain.

Blood/Coagulation : anaemia, abnormal differential, thrombocytopaenia, purpura, ESR increased.

 

For Obstetrics and Gynaecology 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)


 

When used for cervical ripening for labour and delivery


·          Hyperstimulation of the uterus which may progress to uterine tetany with marked impairmentof uteroplacental blood flow.

·          Retained placenta

·          Amniotic fluid embolism

·          Foetal bradycardia

·          Foetal and maternal death


 

OVERDOSAGE

Clinical signs that may indicate an overdose are sedation, tremor, convulsions, dyspnea, abdominal pain, diarrhoea, 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.

 

STORAGE AND HANDLING INSTRUCTIONS

Store in a cool dry place.

 

PACKAGING INFORMATION

TECTOR-200 is available in a pack of 4 tablets.

 

Manufactured in India by: 

ZEE LABORATORIES

47, Industrial Area, Paonta Sahib-173025.

 

 

 

 

 

 


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