Migrasaf

Uses

Stimulation of gut motility in-

• Non-ulcer dyspepsia
• Oesophageal reflux, reflux oesophagitis and gastritis
• Diabetic gastroparesis
• Functional dyspepsia
• Speeding barium transit in follow through radiological studies

Prevention and symptomatic relief of acute nausea and vomiting from any cause including cytotoxic therapy, radiotherapy and antiparkinsonism therapy.

In the prophylactic treatment of migraine.

Flunarizine is used for

• Prophylaxis of classic (with aura) or common (without aura) migraine
• Symptomatic treatment of vestibular vertigo (due to a diagnosed functional disorder of the vestibular system).
• Peripheral Vascular Disease (PVD)
• Motion sickness
• Refractory epilepsy resistant to conventional antiepileptic therapy.

Migrasaf is also used to associated treatment for these conditions: Diabetic Gastroparesis, Dyspepsia, Erosive Esophagitis, Gastrointestinal Symptoms, Non-erosive Reflux Esophagitis Disease (NERD), Upper gastrointestinal motility disordersSevere Migraine

How Migrasaf works

Domperidone acts as a gastrointestinal emptying (delayed) adjunct and peristaltic stimulant. The gastroprokinetic properties of domperidone are related to its peripheral dopamine receptor blocking properties. Domperidone facilitates gastric emptying and decreases small bowel transit time by increasing esophageal and gastric peristalsis and by lowering esophageal sphincter pressure. Antiemetic: The antiemetic properties of domperidone are related to its dopamine receptor blocking activity at both the chemoreceptor trigger zone and at the gastric level. It has strong affinities for the D2 and D3 dopamine receptors, which are found in the chemoreceptor trigger zone, located just outside the blood brain barrier, which - among others - regulates nausea and vomiting

Flunarizine inhibits the influx of extracellular calcium through myocardial and vascular membrane pores by physically plugging the channel. The decrease in intracellular calcium inhibits the contractile processes of smooth muscle cells, causing dilation of the coronary and systemic arteries, increased oxygen delivery to the myocardial tissue, decreased total peripheral resistance, decreased systemic blood pressure, and decreased afterload.

Dosage

Migrasaf dosage

Adults: 10 - 20 mg every 4 - 8 hours daily

Children: 0.2 - 0.4 mg/kg every 4 - 8 hours daily.

Domperidone tablet and suspension should be taken 15 - 30 minutes before a meal. For acute nausea and vomiting, maximum period of treatment is 12 weeks.

Migraine Prophylaxis:

• Starting Dose: 10 mg at night in patients less than 65 years of age and 5 mg daily in patients older than 65 years. If, during this treatment depressive, extrapyramidal or other unacceptable symptoms occur, administration should be discontinued. If, after 2 months of this initial treatment, no significant improvement is observed, the patient should be considered a non-responder and administration should be discontinued.
• Maintenance Treatment: If a patient is responding satisfactorily and if a maintenance treatment is needed, the dose should be decreased to 5 days treatment at the same daily dose with two successive medicine free days every week. Even if the prophylactic maintenance treatment is successful and well tolerated, it should be interrupted after 6 months and it should be re-initiated only if the patient relapses.

Peripheral Vascular disease: 10 mg twice daily, up to 30 mg per day if required.

Vertigo & motion sickness: 10-20 mg daily for adults and 5 mg daily for children (> 40 kg).

Epileptic seizure: 15-20 mg daily in adults and 5 to 10 mg daily for children as an add-on therapy

Side Effects

Domperidone may produce hyperprolactinemia which may cause galactorrhea & breast enlargement, soreness and reduced libido. It may rarely cause dry mouth, thirst, headache, nervousness, drowsiness, diarrhea, skin rash and itching.

Flunarizine is well tolerated and seldom causes serious side effects. The main adverse effects experienced by the patients are as follows:

Central nervous system: Depression, drowsiness, sedation, and anxiety.

Gastrointestinal: Heart burn, nausea, emesis, dry mouth, gastralgia.

Miscellaneous: Weight gain, and/or increased appetite, asthenia, muscle aches, skin rash, and galactorrhea in female patients on oral contraceptives.

Toxicity

Side effects include galactorrhea, gynecomastia, or menstrual irregularities.

-Flunarizine should be used with care in patients with depression or those being prescribed other agents, such as phenothiazines, concurrently, which may cause extrapyramidal side-effects. -Acute overdosage has been reported and the observed symptoms were sedation, agitation and tachycardia. -Treatment of acute overdosage consists of charcoal administration, induction of emesis or gastric lavage, and supportive measures. No specific antidote is known.

Precaution

Domperidone should be used with absolute caution in case of children because there may be an increased risk of extra-pyramidal reactions in young children because of an incompletely developed blood brain barrier.

Since sedation or drowsiness occur in some patients during treatment with flunarizine hydrochloride, patients should be cautioned against activities which require alertness or rapid, precise responses (e.g. operating machinery or a motor vehicle) until the response to the drug has been determined.

Interaction

Domperidone may reduce the hypoprolactinaemic effect of bromocriptine. Anti-muscarinics and opioid analgesics may antagonize the action of Domperidone on gastrointestinal function.

Galactorrhoea has been reported in few women on oral contraceptives within the first two months of Flunarizine treatment. Hepatic enzyme inducers such as Carbamazepine and Phenytoin may interact with flunarizine by increasing its metabolism. So an increase in dosage of flunarizine may be required.

Elimination Route

85% following oral administration.

Half Life

7 hours

18 days

Pregnancy & Breastfeeding use

Use in pregnancy: The safety of this drug has not been established for pregnant women. So it is not recommended during pregnancy.

Use in lactation: Domperidone may precipitate galactorrhea and improve postnatal lactation, which is secreted in breast milk but in very small quantities insufficient to be considered harmful.

Safety in pregnancy and lactation has not been established.

Contraindication

Domperidone is contraindicated to the patients who have hypersensitivity to this drug and in case of neonates.

Hypersensitivity to Flunarizine. Flunarizine is contra-indicated in patients with a history of depressive illness, or with pre-existing symptoms of Parkinson's disease or other extrapyramidal disorders.

Acute Overdose

Overdose has been reported primarily in infants and children. Symptoms of overdosage may include disorientation, somnolence and extrapyramidal reactions. There is no specific antidote to domperidone, but in the event of overdose, the administration of activated charcoal may be useful. Anticholinergics, antiparkinson drugs may be useful in controlling extrapyramidal reactions. The patient should be observed closely and supportive measures employed.

Storage Condition

Store in a cool dry place protected from light. Keep out of reach of children.

Store at a cool & dry place, protected from light and moisture. Keep out of reach of the children.

Innovators Monograph

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