Dosage of Omepral D in details
It is recommended to take oral Omepral 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 Omepral 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).Omepral D interactions
Concomitant administration of anticholinergic drugs may antagonise the antidyspeptic effect of Omepral D.
Antacids and antisecretory drugs should not be given simultaneously with oral formulations of Omepral D as they lower its oral bioavailability.
The main metabolic pathway of Omepral D is through CYP3A4. In vitro and human data show that the concomitant use of drugs that significantly inhibit this enzyme may result in increased plasma levels of Omepral D. Examples of potent CYP3A4 inhibitors include: Azole antifungals eg, fluconazole*, itraconazole, ketoconazole* and voriconazole*; macrolide antibiotics eg, clarithromycin* and erythromycin*; HIV protease inhibitors eg, amprenavir, atazanavir, fosamprenavir, indinavir, nelfinavir, ritonavir and saquinavir; calcium antagonists eg, diltiazem and verapamil; amiodarone*; aprepitant; nefazodone; telithromycin*.
(*Also prolong the QTc interval; see Contraindications.)
Separate pharmacokinetic/pharmacodynamic interaction studies with oral ketoconazole or oral erythromycin in healthy subjects confirmed a marked inhibition of Omepral D's CYP3A4 mediated first-pass metabolism by these drugs.
With the combination of Omepral D 10 mg 4 times daily and ketoconazole 200 mg twice daily, a mean QTc prolongation of 9.8 msec was seen over the observation period, with changes at individual time points ranging from 1.2-17.5 msec. With the combination of Omepral D 10 mg 4 times daily and erythromycin 500 mg 3 times daily, mean QTc over the observation period was prolonged by 9.9 msec, with changes at individual time points ranging from 1.6-14.3 msec. Both the Cmax and AUC of Omepral D at steady-state were increased approximately 3-fold in each of these interaction studies.
The contribution of increased plasma concentrations of Omepral D to the observed effect on QTc is not known.
In these studies, Omepral D monotherapy at 10 mg 4 times daily resulted in increases in mean QTc of 1.6 msec (ketoconazole study) and 2.5 msec (erythromycin study), while ketoconazole monotherapy (200 mg twice daily) and erythromycin monotherapy (500 mg 3 times daily) led to increases in mean QTc of 3.8 and 4.9 msec, respectively, over the observation period.
In another multiple-dose study in healthy subjects, no significant increases in QTc were noted during steady-state treatment with Omepral D monotherapy at 40 mg 4 times daily (total daily dose of 160 mg, which is double the maximum daily dose) at plasma concentrations of Omepral D that were at least similar to those found in the combination arms of the interaction studies.
Theoretically, since Omepral D has gastrokinetic effects, it could influence the absorption of concomitantly orally administered drugs, particularly those with sustained release or enteric-coated formulations. However, in patients already stabilised on digoxin or paracetamol, concomitant administration of Omepral D did not influence the blood levels of these drugs.
Omepral D may also be given with neuroleptics, the action of which it does not potentiate; dopaminergic agonists (bromocriptine, L-dopa), whose unwanted peripheral effects eg, digestive disorders, nausea and vomiting, it suppresses without counteracting their central properties.
References
- FDA/SPL Indexing Data. "5587267Z69: The UNique Ingredient Identifier (UNII) is an alphanumeric substance identifier from the joint FDA/USP Substance Registration System (SRS).". https://www.fda.gov/ForIndustry/Data... (accessed September 17, 2018).
- MeSH. "Dopamine Antagonists". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).
- European Chemicals Agency - ECHA. "Domperidone: The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". https://echa.europa.eu/information-o... (accessed September 17, 2018).
Reviews
The results of a survey conducted on ndrugs.com for Omepral D are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Omepral D. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.User reports
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Information checked by Dr. Sachin Kumar, MD Pharmacology
