Omipace D Uses

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What is Omipace D?

Omipace D is a medicine that increases the movements or contractions of the stomach and bowel. Omipace D is also used to treat nausea and vomiting caused by other drugs used to treat Parkinson's Disease.

Omipace D is to be given only by or under the immediate supervision of your doctor.

Omipace D indications

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Dyspeptic symptom complex often associated with delayed gastric emptying, gastroesophageal reflux disease (GERD) or esophagitis: Epigastric sense of fullness, feeling of abdominal distention, upper abdominal pain, flatulence (gassiness), eructation (belching), and heartburn.

Short-term treatment of nausea and vomiting of various origins including functional, organic, infectious, diabetic origin, or induced by radiotherapy or medicine therapy. (It is not considered suitable for chronic nausea and vomiting, nor for the routine prophylaxis of postoperative vomiting.)

Treatment of nausea and vomiting induced by dopamine agonists ie, L-dopa and bromocriptine used in Parkinson's disease.

Omipace D may also be given as needed, together with paracetamol for the symptomatic treatment of nausea and vomiting associated with migraine.

Uses of Omipace D in details

Omipace D is used to treat vomiting or nausea caused due to indigestion, diseases or drugs. It is also used to relieve fullness of stomach, belching and heavy bloating, gas and heartburn for a longer period up to 2 weeks.

Omipace D description

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Omipace D is a synthetic anticoagulant and an indanedione derivative. It prevents the formation of active procoagulation factors II, VII, IX, and X, as well as the anticoagulant proteins C and S, in the liver by inhibiting the vitamin K mediated gamma-carboxylation of precursor proteins.

Omipace D dosage

It is recommended to take oral Omipace D before meals. If taken after meals, absorption of the drug is somewhat delayed.

Adults and Adolescents >12 years and weighing ≥35 kg: Tablets: One to two 10-mg tablet 3-4 times/day, with a maximum daily dose of 8 tablets (80 mg).

Oral Suspension:

10-20 mL (of oral susp containing Omipace D 1 mg/mL) 3-4 times/day, with a maximum daily dose of 80 mL.

Infants and Children: 0.25-0.5 mg/kg 3-4 times/day with a maximum daily dose of 2.4 mg/kg (but do not exceed 80 mg/day).

Tablets are unsuitable for use in children weighing <35 kg.

Oral Suspension:

0.25-0.5 mg/kg 3-4 times/day with a maximum dose of 2.4 mg/kg (not exceeding 80 mL).

Omipace D interactions

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The concomitant administration of Omipace D with phenothiazines, butyrophenones and rauwolfia alkaloids may induce the endocrine disturbances or extrapyramidal disorders. If necessary, monitored carefully and administered cautiously.

Should be administered cautiously in patients receiving digitalis preparations.

The concomitant administration of Omipace D with anticholinergic agents may compromise the beneficial effects of Omipace D because of depressing the promoting action of gastrointestinal motility.

Theologically, Omipace D may have an effect on the absorption of oral preparations, especially slow-releasing or enteric-coated preparations because of increasing gastric motility. But in patients stabilized with digoxin or acetaminophen, the concomitant administration of Omipace D had no effect on plasma concentration of these drugs.

It is not reported that Omipace D enhances the effect of neuroleptics.

Omipace D inhibits peripheral adverse reactions eg, dyspepsia, nausea, vomiting, induced by dopamine agonist (eg, bromocriptine, levodopa), but has no effect on central nervous system.

As the concomitant administration of Omipace D with antacids or acid secretion inhibitors lowers biologic activity of Omipace D, these drugs should not be used together.

The actions of Omipace D on gastrointestinal function may be antagonised by antimuscarinics and opioid analgesics.

Omipace D side effects

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What are the possible side effects of Omipace D?

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Clinical Trial Data: The safety of Omipace D was evaluated in 1221 patients with gastroparesis, dyspepsia, gastro-oesophageal reflux disorder (GERD) or other related conditions in 45 clinical trials included in the safety database. All patients were ≥15 years and received at least 1 dose of oral Omipace D (Omipace D base). Slightly fewer than one-half (553/1221) of patients were diabetic. The median total daily dose was 80 mg (range 10-160 mg), with 230 patients receiving a dose >80 mg. Median duration of exposure was 56 days (range 1-2248 days).

Adverse drug reactions (ADRs) reported by ≥1% of patients treated with oral Omipace D in these 45 clinical trials (n=1221) are the following: Psychiatric Disorders: Depression (2.5%), anxiety (1.6%), decreased libido/loss of libido (1.5%).

Nervous System Disorders: Headache (5.6%), somnolence (2.5%), akathisia (1%).

Gastrointestinal Disorders: Diarrhoea (5.2%).

Skin and Subcutaneous Tissue Disorders: Rash (2.8%), pruritus (1.7%).

Reproductive System and Breast Disorders: Breast enlargement/gynaecomastia (5.3%), breast tenderness (4.4%), galactorrhoea (3.3%), amenorrhoea (2.9%), breast pain (2.3%), irregular menstruation (2%), lactation disorder (1.6%).

General Disorders and Administration Site Conditions: Asthenia (1.9%).

ADRs that occurred in <1% of Omipace D-treated patients in the 45 clinical trials (n=1221) are the following: Immune System Disorders: Hypersensitivity (0.2%).

Skin and Subcutaneous Disorders: Urticaria (0.7%).

Reproductive System and Breast Disorders: Breast discharge (0.8%), breast swelling (0.5%).

Dry mouth has been reported with over-the-counter use of Omipace D.

Post-Marketing: In addition to the adverse effects reported during clinical studies and previously mentioned, the following adverse drug reactions provided the frequencies according to the following convention: Very common (≥1/10), common (≥1/100 and <1/10); uncommon (≥1/1000 and <1/100); rare (≥1/10,000 and <1/1000); very rare (<1/10,000, including isolated reports).

The following ADRs are presented by frequency category based on spontaneous reporting rates: Immune System Disorders: Very Rare: Anaphylactic reactions (including anaphylactic shock).

Psychiatric Disorders: Very Rare: Agitation, nervousness.

Nervous System Disorders: Very Rare: Extrapyramidal disorder, convulsion.

Cardiac Disorders: Very Rare: Sudden cardiac death*, serious ventricular arrhythmias*.

Skin and Subcutaneous Tissue Disorders: Very Rare: Angioedema.

Renal and Urinary Disorders: Very Rare: Urinary retention.

Investigations: Very Rare: Abnormal liver function test; increased blood prolactin.

Note: *Based on epidemiology data (as follows).

As the hypophysis is outside the blood-brain barrier, Omipace D may cause an increase in prolactin levels. In rare cases, this hyperprolactinaemia may lead to neuro-endocrinological side effects eg, galactorrhoea, gynaecomastia and amenorrhoea.

Extrapyramidal disorder occurs primarily in neonates and infants.

Other central nervous system-related effects of convulsion and agitation are also reported primarily in infants and children.

An increase in the risk of serious ventricular arrhythmias and sudden cardiac death has been reported in some epidemiology studies. Due to the limitations of these data, risk factors and the exact frequency of these adverse reactions could not be defined.

Omipace D contraindications

Hypersensitivity to Omipace D or any ingredient of Omipace D.

If patients are taking oral ketoconazole, fluconazole, voriconazole, erythromycin, clarithromycin, telithromycin, amiodarone, selective serotonin reuptake inhibitors, HIV protease inhibitors, calcium antagonists which can increase plasma concentrations of Omipace D, leading to a prolonged QTc interval. These medicines can increase plasma concentrations of Omipace D leading to a prolonged QTc interval. Patients with long QT syndrome develop a very fast heart rhythm disturbance leading to a sudden loss of consciousness.

Gastrointestinal hemorrhage (bleeding), obstruction, perforation or conditions where gastrointestinal stimulation or movements may be dangerous.

Prolactin-releasing pituitary tumor (prolactinoma).

Active ingredient matches for Omipace D:

Domperidone

Omeprazole


Unit description / dosage (Manufacturer)Price, USD
Omipace D 20+10 Capsule$ 0.05
OMIPACE D 10MG/20MG CAPSULE 1 strip / 10 capsules each (Ratchet Biotech Pvt Ltd)$ 0.54
Omipace D Capsule (Ratchet Biotech Pvt Ltd)$ 0.05

List of Omipace D substitutes (brand and generic names):

Omipace 20mg Capsule (Ratchet Biotech Pvt. Ltd.)$ 0.05
Capsule; Oral; Omeprazole 10 mg (Biopharm)
Capsule; Oral; Omeprazole 20 mg (Biopharm)
Capsules; Oral; Omeprazole 10 mg (Biopharm)
Capsules; Oral; Omeprazole 20 mg (Biopharm)
Omiplas 20 mg Capsule (Plasmid Health Care Pvt. Ltd.)$ 0.06
Omiplas D 20+10 Tablet (Plasmid Health Care Pvt. Ltd.)$ 0.07
Omiplus 20+10 Capsule (Pharma Synth Formulations Ltd.)$ 0.05
OMIPRAA cap 20 mg x 15's (Pranshu)
Omiprex 20 mg Capsule (Kentreck Labs Pvt Ltd.)$ 0.04
OMIPREX 20 MG CAPSULE 1 strip / 10 capsules each (Kentreck Labs Pvt Ltd.)$ 0.48
Omiprex 20mg Capsule (Kentreck Labs Pvt Ltd.)$ 0.05
Omiprex D 20+10 Capsule (Kentreck Labs Pvt Ltd.)$ 0.05
OMIPREX D 10 MG/20 MG CAPSULE 1 strip / 10 capsules each (Kentreck Labs Pvt Ltd.)$ 0.12
Omiprex D 10 mg/20 mg Capsule (Kentreck Labs Pvt Ltd.)$ 0.01
OMIQ D TABLET 1 strip / 10 tablets each (Que Pharma Pvt Ltd)$ 0.40
Omired 20mg CAP / 10x10 (Redline Healthcare)$ 4.46
Omired 20 mg Capsule (Redline Healthcare)$ 0.04
Omis 20 mg Capsule (Sanjeevani Bio-Tech (P) Ltd)$ 0.05
OMIS 20MG CAPSULE 1 strip / 10 capsules each (Sanjeevani Bio-Tech (P) Ltd)$ 0.54
Omis 20mg Capsule (Sanjeevani Bio-Tech (P) Ltd)$ 0.05
Omis D 20+10 Capsule (Sanjeevani Bio-Tech (P) Ltd)$ 0.06
Omisal 20 mg Capsule (Salvo Healthcare Pvt Ltd)$ 0.04
Omisal D 20+10 Capsule (Salvo Healthcare Pvt Ltd)$ 0.05
Omisan 20mg CAP / 10x10 (Santo Formulations)$ 5.10
Omisan 20 mg Capsule (Santo Formulations)$ 0.05
Omisat 20 mg Tablet (Satven And Mer)$ 0.04
OMISAT 20MG CAPSULE 1 strip / 10 capsules each (Satven And Mer)$ 0.39
Omisat 20mg Capsule (Satven And Mer)$ 0.04
OMISEC 20 MG CAPSULE 1 strip / 10 capsules each (Aristo Pharmaceuticals Pvt Ltd)$ 0.09
Omisec 20mg Capsule (Aristo Pharmaceuticals Pvt Ltd)$ 0.01
Omisun 20mg CAP / 10 (Sungrace Pharma Pvt. Ltd.)$ 0.42
Omisun 20 mg Capsule (Sungrace Pharma Pvt. Ltd.)$ 0.04
Omisun D 20+10 Capsule (Sungrace Pharma Pvt. Ltd.)$ 0.05
Omitab 20mg TAB / 10 (Ethix Health Care)$ 0.36
Omitab 20 mg Tablet (Ethix Health Care)$ 0.04
Omitec 20 mg Capsule (Retec Formulations Pvt. Ltd.)$ 0.05
Omitec D 20+10 Capsule (Retec Formulations Pvt. Ltd.)$ 0.07
OMITIN 20MG CAPSULE 1 strip / 10 capsules each (Seagull Labs (I) Pvt Ltd)$ 0.09
Omitin 20mg Capsule (Seagull Pharmaceutical Pvt Ltd)$ 0.01

References

  1. DailyMed. "OMEPRAZOLE MAGNESIUM: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
  2. PubChem. "omeprazole". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
  3. PubChem. "domperidone". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology

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