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Over Active Bladder –Quality of Life Implications
OAB is a clinical syndrome defined as urgency with or without urge incontinence usually with frequency and nocturia. It is a common problem: one... Read More
 
Mictonorm

Composition:

Active Ingredients:
Coated tablets containing 15 mg of propiverine hydrochloride
equivalent  to 13.64 mg propiverine.

Inactive ingredients:

Lactose monohydrate, powdered cellulose, magnesium stearate,
sucrose, talk, heavy kaolin, calcium carbonate, titanium dioxide
(E171), acacia gum, colloidal anhydrous silica, Macrogol 6000, glucose monohydrate and montan wax.

Pharmacodynamics:

Mictonorm belongs to the antimuscarinic group, that interfere with the process
 that causes the bladder to contract thus improving the storage capacity of the bladder
Mode of actions of Mictonorm are:

1- Blocking the acetyl choline receptors
2 - Direct smooth muscle relaxing effect (detrusor muscle) due to calcium channel blocking.

Pharmacokinetics:

Immediately after oral administration Mictonorm is readily absorbed from the gastrointestinal tract with peak plasma level is reached 2-3 hours after oral administration, while steady state plasma concentration is reached after 4-5 days.
 After oral administration Mictonorm undergoes extensive first pass metabolism with average absolute bioavailability about 40.5 %.
Protein binding is about 90% for parent compound and 60% for the principal metabolite (propiverine N-Oxide)
The routs of excretion are urine, bile and feces.
The elimination half life is about 14.1 hours.

Indications:

Treatment of urinary incontinence, urgency and frequency in patients with idiopathic detrusor overactivity (overactive bladder) or neurogenic detrusor overactivity (detrusor hyperreffexia) from spinal cord injuries, e.g. transverse lesion paraplegia.

Contraindications:

Do not take Mictonorm if you 

  • Hypersensitivity to the active substance or any of the excipients.
  • Patients suffering from:

  • obstruction of the bowel
  • significant degree of bladder outflow obstruction where urinary retention may be anticipated.
  • myasthenia gravis
  • intestinal atony
  • severe ulcerative colitis
  • toxic megacolon 
  • uncontrolled angle closure glaucoma
  • moderate or sever hepatic impairment
  • tachyarrhythmia

  • Pregnancy and lactation:

    Mictonorm should not be used during pregnancy and lactation.
    Adverse events:

    The following adverse events have been reported:

    Very common: dry mouth
    Common: abnormal vision and difficulty in focusing, constipation, fatigue, headache, stomach pain, indigestion
    Uncommon: feeling sick and vomiting, dizziness, trembling (tremor), difficulty in passing urine (urinary retention), flushing, altered sense of taste, decreased blood pressure with drowsiness
    Rare: rash due to idiosyncrasy (propiverine hydrochloride) or hypersensitivity to excipients.
    Very rare: irregular heart beat, restlessness, confusion
    All undesirable effects are transient and recede after maximum 1-4 days of dose adjustments or termination.

    Warnings:

    • Mictonorm should be used with caution in patients with
    • autonomic neuropathy.
    • severe kidney problems
    • moderate or severe liver problems
    • severe heart failure
    • enlargement of the prostate gland
    • hiatus hernia with reflux oesophagitis
    • Cardiac arrhythmia and tachycardia
    Propiverine hydrochloride, like other anticholinergics, induces mydriasis, therefore the risk to induce acute angle closure glaucoma may be increased.
    Pollakiuria and nocturia due to renal disease, organic bladder diseases or congestive heart failure should be ruled out prior to treatment.

    Precautions:

    During long term therapy hepatic enzyme should be monitored as reversible changes might occur in rare cases. Monitoring intraocular pressure is recommended in patients at risk of developing glaucoma. Attention should be paid to residual urine volume in cases of urinary tract infection.

    Driving and operating machinery:

    Mictonorm can sometimes cause sleepiness and blurred vision. You should not drive or operate machinery if you suffer from sleepiness and blurred vision.

    Drug to drug Interactions:

    You should tell your doctor if you are taking or have taken any of the following medicines as they may interact with your Mictonorm:
    antidepressants (e.g. imipramine, clomipramine and amitryptiline)

    • sleeping tablets (e.g. benzodiazepines)
    • anticholinergics taken by mouth or injection (usually used to treat asthma, stomach cramps, eye problems or urinary incontinence)
    • amantadine (used to treat flu)
    • neuroleptics such as promazine, olanzapine, quetiapine (drugs used to treat psychotic disorders or anxiety)
    • beta stimulants (drugs used to treat asthma)
    • isoniazide (a treatment for tuberculosis) and
    • antifungals (e.g. ketoconazole)
    • metoclopramide (used to treat nausea and vomiting)

    Nevertheless, it may still be all right for you to take Mictonorm. Your doctor will be able to decide what is suitable for you.

    Dosage and administration:

    The recommended daily doses are:
    For adults and elderly one 15 mg tablet twice a day, this may be increased to three times a day. Some patients may respond to one 15 mg tablet a day. For neurogenic detrusor over activity the recommended dose is one 15 mg tablet three times a day.

    Packaging:

    Packages of 4 strips each are containing 7 tablets.

    Storage:

    Do not store Mictonorm above 30 C.

    Instruction to the patients

    • Keep out of reach and sight of children
    • Do not use Mictonorm after the expiry date, which is stated on the blister and carton after EXP. The expiry date refers to the last day of the month.
    • The coated tablets should be swallowed whole before meals with adequate fluid.
    • Please, do not take in the coated tablets with a high fat meal.
    • If you have accidentally taken more than your prescribed dose, contact your nearest casualty department or tell your doctor or pharmacist immediately. Remember to take the pack and any remaining orodispersible tablets with you.
    • If you forget to take Mictonorm  do not worry. Take the recommended dose as soon as you remember, unless it is nearly time for the next dose. Then take the next dose at the right time. Do not take a double dose to make up for a forgotten dose.
     
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