Spinil D

Uses

It is mainly used for the symptomatic treatment of nausea and vertigo due to Meniere's disease and other labyrinthine disturbances and for the prevention and treatment of motion sickness. It is also used in the management of various vascular disorders.

Cerebral circulatory disorders:

• Prophylaxis and maintenance therapy for symptoms of cerebral vascular spasms and arteriosclerosis such as dizziness, ear buzzing (tinnitus), vascular headache, unsociability and irritability, fatigue, sleep rhythm disorders such as premature awakening, involutional depressions, loss of memory and lack of concentration, incontinence and other disorders due to aging.
• Sequel of cerebral and cranial trauma.
• Post-apoplectic disorders.
• Migraine.

Peripheral circulatory disorders: Prophylaxis and maintenance therapy for symptoms of vascular spasms and arteriosclerosis (obliterating arteritis, thromboangitis obliterans, Raynaud's disease, diabetes, acrocyanosis, perrio, etc.) such as: intermittent claudication, trophic disturbances, pregangrene, trophic and varicose ulcers, paraesthesia, nocturnal cramps, cold extremities.

Disorders of balance:

• Prophylaxis and maintenance therapy for symptoms of labyrinthine arteriosclerosis, vestibular irritability, Meniere's syndrome, such as vertigo, dizziness, giddiness, syncopal attacks, tinnitus, nystagmus, nausea and vomiting.
• Prophylaxis of motion sickness.

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.

Spinil D is also used to associated treatment for these conditions: Balance Disorders, Dizziness, Motion Sickness, Nausea, Peripheral Artery Disease (PAD), Raynaud's Phenomenon, Inadequate cerebral circulation, Peripheral vasculopathyDiabetic Gastroparesis, Dyspepsia, Erosive Esophagitis, Gastrointestinal Symptoms, Non-erosive Reflux Esophagitis Disease (NERD), Upper gastrointestinal motility disorders

How Spinil D works

Cinnarizine inhibits contractions of vascular smooth muscle cells by blocking L-type and T-type voltage gated calcium channels. Cinnarizine has also been implicated in binding to dopamine D2 receptors, histamine H1 receptors, and muscarinic acetylcholine receptors.

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

Dosage

Spinil D dosage

Peripheral vascular disease:

• Adult: 75 mg bid or tid.

Cerebrovascular disorders:

• Adult: 75 mg once daily.

Motion sickness:

• Adult: 30 mg 2 hr before travel then 15 mg 8 hrly during the journey if necessary.
• Child: 5-12 yr 15 mg 2 hr before travel then 7.5 mg 8 hrly during the journey as necessary.

Vertigo and vestibular disorders:

• Adult: 30 mg tid or 75 mg 1-2 times daily.
• Child: 5-12 yr 15 mg tid.

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.

Side Effects

Side effects such as somnolence and gastrointestinal disturbances are extremely rare. They are transient and may be readily prevented by achieving the optimal dosage gradually. Combination therapy with other drugs is possible. Whenever indicated, caution should be taken in hypotension (high doses). Rarely, extrapyramidal symptoms in elderly on prolonged therapy.

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.

Toxicity

Side effects include galactorrhea, gynecomastia, or menstrual irregularities.

Precaution

Patient with hypotension (high dose), Parkinson's disease, porphyria. Renal and hepatic impairment. Childn. Pregnancy and lactation.

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.

Interaction

Concurrent use of alcohol, CNS depressants or tricyclic antidepressants may potentiate the sedative effects of either these drugs or of Cinnarizine. Therefore, it is advisable to avoid these drugs while taking Cinnarizine.

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

Half Life

7 hours

Pregnancy & Breastfeeding use

Pregnancy Category C. The safety of Cinnarizine in human pregnancy has not been established. Therefore, it is not advisable to administer Cinnarizine in pregnancy.

Lactation: It is not known if Cinnarizine is excreted in human breast milk. Use of Cinnarizine during breast feeding is not advised.

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.

Contraindication

Contraindicated in Known hypersensitivity to Cinnarizine, Parkinson’s disease, Hypotension

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

Special Warning

Neonates: Cinnarizine is not indicated in neonates.

Acute Overdose

Symptoms: Consciousness alterations ranging from somnolence to stupor and coma, vomiting, extrapyramidal symptoms, hypotonia; seizures may occur in young children.

Management: Symptomatic and supportive treatment. May consider admin of activated charcoal within 1 hr of ingestion.

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.

Innovators Monograph

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