Overdose of Omper D in details
Symptoms: Overdose has been reported primarily in infants and children. Symptoms of overdose may include agitation, altered consciousness, convulsion, disorientation, somnolence and extrapyramidal reactions.
Treatment: There is no specific antidote to Omper D, but in the event of overdose, gastric lavage as well as the administration of activated charcoal may be useful. Close medical supervision and supportive therapy is recommended. Anticholinergic or antiparkinson drugs may be helpful in controlling the extrapyramidal reactions.
Omper D warnings
Do not take it in larger amounts than recommended, or for longer than 3 months. High doses or long-term use of metoclopramide may cause tremors or other uncontrollable muscle movements, especially in older women.
Stop using metoclopramide and call your doctor at once if you have tremors or uncontrolled muscle movements, fever, stiff muscles, confusion, sweating, fast or uneven heartbeats, rapid breathing, depressed mood, thoughts of suicide or hurting yourself, hallucinations, anxiety, agitation, seizure, or jaundice (yellowing of your skin or eyes).
After you stop taking metoclopramide, you may have unpleasant withdrawal symptoms such as headache, dizziness, or nervousness. Talk to your doctor about how to avoid withdrawal symptoms when stopping the medication.
FDA pregnancy category B. metoclopramide is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Metoclopramide can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.
Avoid drinking alcohol. It can increase some of the side effects of metoclopramide. Metoclopramide can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.
What should I discuss with my healthcare provider before taking Omper D?
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For Omper D, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to Omper D or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Children—Studies on Omper D have been done only in adult patients, and there is no specific information comparing use of Omper D in children with use in other age groups.
Geriatric
Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing the use of Omper D in the elderly with use in other age groups.
Breast Feeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Interactions with Medicines
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving Omper D, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using Omper D with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Amifampridine
- Bepridil
- Cisapride
- Darunavir
- Dronedarone
- Fluconazole
- Ketoconazole
- Mesoridazine
- Pimozide
- Piperaquine
- Posaconazole
- Saquinavir
- Sparfloxacin
- Terfenadine
- Thioridazine
- Ziprasidone
Using Omper D with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Abiraterone
- Alfuzosin
- Alprazolam
- Amiodarone
- Amitriptyline
- Amlodipine
- Amoxapine
- Amprenavir
- Anagrelide
- Apomorphine
- Aprepitant
- Aripiprazole
- Arsenic Trioxide
- Artemether
- Asenapine
- Astemizole
- Atazanavir
- Atorvastatin
- Azithromycin
- Bedaquiline
- Bicalutamide
- Boceprevir
- Buserelin
- Ceritinib
- Chloroquine
- Chlorpromazine
- Cimetidine
- Ciprofloxacin
- Citalopram
- Clarithromycin
- Clomipramine
- Clozapine
- Cobicistat
- Conivaptan
- Crizotinib
- Cyclobenzaprine
- Cyclosporine
- Dabrafenib
- Dasatinib
- Degarelix
- Delamanid
- Delavirdine
- Desipramine
- Deslorelin
- Diltiazem
- Disopyramide
- Dofetilide
- Dolasetron
- Donepezil
- Doxepin
- Droperidol
- Ebastine
- Eribulin
- Erythromycin
- Escitalopram
- Famotidine
- Felbamate
- Fingolimod
- Flecainide
- Fluoxetine
- Fluvoxamine
- Formoterol
- Fosamprenavir
- Fosaprepitant
- Foscarnet
- Fosphenytoin
- Galantamine
- Gatifloxacin
- Gemifloxacin
- Ginkgo Biloba
- Goldenseal
- Gonadorelin
- Goserelin
- Granisetron
- Halofantrine
- Haloperidol
- Histrelin
- Hydroquinidine
- Hydroxychloroquine
- Ibutilide
- Idelalisib
- Iloperidone
- Imatinib
- Imipramine
- Indinavir
- Isoniazid
- Itraconazole
- Ivabradine
- Lapatinib
- Leuprolide
- Levofloxacin
- Lithium
- Lopinavir
- Lumefantrine
- Mefloquine
- Methadone
- Metronidazole
- Miconazole
- Mifepristone
- Mizolastine
- Moxifloxacin
- Nafarelin
- Nefazodone
- Nelfinavir
- Netupitant
- Nilotinib
- Norfloxacin
- Nortriptyline
- Octreotide
- Ofloxacin
- Ondansetron
- Paliperidone
- Panobinostat
- Paroxetine
- Pasireotide
- Pazopanib
- Pentamidine
- Perflutren Lipid Microsphere
- Perphenazine
- Pipamperone
- Probucol
- Procainamide
- Prochlorperazine
- Promethazine
- Propafenone
- Protriptyline
- Quetiapine
- Quinidine
- Quinine
- Ranitidine
- Ranolazine
- Rilpivirine
- Risperidone
- Ritonavir
- Salmeterol
- Selegiline
- Sertindole
- Sevoflurane
- Sodium Phosphate
- Sodium Phosphate, Dibasic
- Sodium Phosphate, Monobasic
- Solifenacin
- Sorafenib
- Sotalol
- Sunitinib
- Tacrolimus
- Tamoxifen
- Telaprevir
- Telavancin
- Telithromycin
- Tetrabenazine
- Ticagrelor
- Tizanidine
- Tolterodine
- Toremifene
- Trazodone
- Trifluoperazine
- Trimipramine
- Triptorelin
- Vandetanib
- Vardenafil
- Vemurafenib
- Venlafaxine
- Verapamil
- Vilanterol
- Vinflunine
- Voriconazole
- Vorinostat
Interactions with Food/Tobacco/Alcohol
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using Omper D with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use Omper D, or give you special instructions about the use of food, alcohol, or tobacco.
- Grapefruit Juice
Other Medical Problems
The presence of other medical problems may affect the use of Omper D. Make sure you tell your doctor if you have any other medical problems, especially:
- Bleeding from the stomach or other problems involving the bowels
- Pituitary (brain) tumor
- Liver disease
- Medicine sensitivity to Omper D
Omper D precautions
General Precautions: As Omper D is mainly metabolized in the liver, it should be administered cautiously in patients with liver injury.
In patients with severe renal impairment (serum creatinine 6 mg/100 mL). The elimination t½ is prolonged from 7.4 hrs to 20.8 hrs, but the plasma concentration of Omper D is lower than that in healthy volunteers. As very small proportion of Omper D is excreted in the urine as unchanged drug, it is unnecessary to control the dosage in the first administration. But in repeated administration, frequency of dosing and dosage should be decreased according to the severity of renal impairment. The condition of patients receiving decreased long-term therapy should be monitored regularly.
Use in pregnancy & lactation: Although studies in animals, with the dosage of 160 mg/kg/day and general clinical use of Omper D in human have not demonstrated teratogenic effects, Omper D should be used in pregnant women and suspected pregnant women only if the potential benefit justifies the potential risk.
It is reported that Omper D is secreted in milk mainly as metabolites in animal studies (rat): Following oral and IV administration of 2.5-mg/kg dose, maximum concentrations in the breast milk were 40 mcg/mL and 800 mcg/mL, respectively. A small proportion of Omper D can be excreted in human milk, but harm to neonates has not been reported. Therefore, Omper D should be used in nursing mothers only if the potential benefit justifies the potential risk.
Use in children: Care should be exercised when Omper D is used in children especially in infants <1 year. Repeated use over 7 days is not recommended in children <3 years.
As Omper D does not readily cross the blood-brain barrier, it does not produce the adverse central effects. However, adverse central effects may occur in infants <1 year with premature blood-brain barrier.
References
- 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).
- DrugBank. "domperidone". http://www.drugbank.ca/drugs/DB01184 (accessed September 17, 2018).
- DrugBank. "omeprazole". http://www.drugbank.ca/drugs/DB00338 (accessed September 17, 2018).
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Information checked by Dr. Sachin Kumar, MD Pharmacology