Premosan Tablets
Metoclopramide Hydrochloride
10mg
Julphar (Gulf Pharmaceutical Industries)
| Pack size | 500's (20's Blister x 25) |
|---|---|
| Dispensing mode | POM |
| Source | UAE |
| Agent | JULPHAR |
| Retail Price | 112.00 AED |
Available as:
Premosan Overview
Premosan generic name is Metoclopramide Hydrochloride. Metoclopramide Hydrochloride is a medication that is used to treat symptoms of gastrointestinal disorders such as nausea, vomiting, and acid reflux. It works by increasing the muscle contractions in the upper digestive tract which helps to move food through the stomach more quickly. It also helps to block the action of a chemical in the brain called dopamine, which can cause nausea and vomiting.
Metoclopramide Hydrochloride is available as an oral tablet, injection and syrup form.
Common side effects can include drowsiness, restlessness, and muscle spasms.
It's important to take Metoclopramide Hydrochloride exactly as prescribed by your doctor and to follow the recommended dosage schedule. It should be used with caution in people with certain medical conditions such as Parkinson's disease, and should not be used in people who have a history of certain neurological conditions, such as tardive dyskinesia.
It's also important to inform your doctor if you are pregnant, breastfeeding or planning to become pregnant.
Indications
Premosan Tablets is used for:
Gastro-oesophageal reflux disease, Diabetic gastric stasis, Nausea and vomiting associated w/ cancer chemotherapy or radiotherapy, Postoperative nausea and vomiting
Adult Dose
Oral
Diabetic gastric stasis
Adult: 10 mg 4 times daily for 2-8 wk.
Nausea and vomiting associated with cancer chemotherapy or radiotherapy
Adult: 10 mg, up to tid. Max duration: 5 days.
Gastro-oesophageal reflux disease
Adult: 10-15 mg 4 times daily, depending on severity of symptoms. If symptoms are intermittent, may give single doses of 20 mg prior to provoking situation. Max duration: 12 wk.
Elderly: 5 mg/dose.
Parenteral
Diabetic gastric stasis
Adult: 10 mg 4 times daily by IM inj or slow IV inj over 1-2 min for up to 10 days. Convert to oral admin when symptoms subside sufficiently.
Intravenous
Prophylaxis of chemotherapy-induced nausea and vomiting
Adult: For highly emetogenic drugs/regimens: Initially, 2 mg/kg by slow inj over at least 15 min, 30 min before chemotherapy. Repeat 2 hrly for 2 doses, then 3 hrly for 3 doses. For less emetogenic drugs/regimens: 1 mg/kg may be used. Max duration: 5 days.
Premedication for radiologic examination of the upper gastrointestinal tract; Intubation of the small intestine
Adult: 10 mg as a single dose by slow inj over 1-2 min.
Parenteral
Prophylaxis of postoperative nausea and vomiting
Adult: 10 mg as a single dose by IM or slow IV inj over at least 3 min.
Hepatic impairment: Severe: Reduce dose by 50%.
Child Dose
Small Bowel Intubation/Radiologic Examination of Upper GI Tract
<6 years old: 0.1 mg/kg IV over 1-2 minutes
6-14 years old: 2.5-5 mg IV over 1-2 minutes
>14 years old: 10 mg IV over 1-2 minutes
Gastroesophageal Reflux Disease
Neonate: 0.15 mg/kg IV q6hr
Infant: 0.1 mg/kg IV/IM/PO q6-8hr 30 minutes before meals and at bedtime
Not to exceed 0.3-0.75 mg/kg/day
Diabetic Gastroparesis
<6 years old: 0.1 mg/kg PO q8hr; not to exceed 0.1 mg/kg
>6 years old: 0.5 mg/kg/day PO divided q8hr
Postoperative Nausea & Vomiting
0.1-2 mg/kg IV q6-8hr PRN
Chemotherapy-Induced Nausea & Vomiting
1-2 mg/kg IV (infused over at least 15 minutes) 30 minutes before chemotherapy; repeat q2-4hr; pretreatment with diphenhydramine decreases risk of extrapyramidal adverse effects
Renal Dose
Renal impairment: CrCl <40 mL/min, decrease dose by 50%; CrCl <10 mL/min, decrease dose by 75%
Administration
Should be taken on an empty stomach. Take ½ hr before meals.
IV Administration
NS is preferred diluent because drug is most stable in this solution
Dose <10 mg: IV push over 1-2 minutes
Dose >10 mg: Dilute in 50 mL D5W or NS, and infuse over at least 15 minutes
Contra Indications
Mechanical obstruction or GI perforation, GI haemorrhage;
Confirmed or suspected pheochromocytoma;
History of neuroleptic or metoclopramide-induced tardive dyskinesia;
Epilepsy, Parkinson's disease;
History of methaemoglobinaemia w/ metoclopramide or of NADH cytochrome-b5 deficiency. Concomitant use w/ levodopa or dopaminergic agonists.
Precautions
- Patients w/ underlying neurological conditions, cardiac conduction disturbances, uncorrected electrolyte imbalance, bradycardia.
- Children, elderly. Renal or hepatic impairment, porphyria, epilepsy, Parkinson's disease, history of depression.
- Ability to drive or operate machineries may be impaired.
- Pregnancy and lactation.
- Monitor patients on prolonged therapy.
- Increased risk of tardive dyskinesia in patients on prolonged or high-dose treatment.
Lactation:
Drug crosses into breast milk;
use caution;
concern may be warranted according to American Academy of Pediatrics
Pregnancy-Lactation
Pregnancy
Published studies, including retrospective cohort studies, national registry studies, and meta-analyses, do not report an increased risk of adverse pregnancy-related outcomes with use of metoclopramide during pregnancy. There are potential risks to neonate following exposure in utero to metoclopramide during delivery; in animal reproduction studies, no adverse developmental effects were observed with oral administration of metoclopramide to pregnant rats and rabbits at exposures about 6 and 12 times the maximum recommended human dose (MRHD)
Metoclopramide crosses the placental barrier and may cause extrapyramidal signs and methemoglobinemia in neonates with maternal administration during delivery; monitor neonates for extrapyramidal signs
Lactation
Limited published data report the presence of metoclopramide in human milk in variable amounts; breastfed infants exposed to metoclopramide have experienced gastrointestinal adverse reactions, including intestinal discomfort and increased intestinal gas formation; metoclopramide elevates prolactin levels; however, published data are not adequate to support drug effects on milk production; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed child from therapy or from underlying maternal condition
Monitor breastfeeding neonates because metoclopramide may cause extrapyramidal signs (dystonias) and methemoglobinemia
Interactions
Increased sedative effects with CNS depressants. GI effects antagonised by antimuscarinics and opioids. Reduces absorption of digoxin. Increases absorption of ciclosporin, levodopa, aspirin, paracetamol. Interferes with hypoprolactinaemic effect of bromocriptine. Inhibits serum cholinesterase and prolongs neuromuscular blockade produced by suxamethonium and mivacurium.
Potentially Fatal: Serotonin syndrome with sertraline (SSRI).
Adverse Effects
Side effects of Metoclopramide Hydrochloride :
>10%
Extrapyramidal symptoms (dystonic reactions in 25% of young adults 18-30 years old)
1-10%
Restlessness (10%), Fatigue (2-10%), Sedation (10%), Headache (4-5%), Dizziness (1-4%), Somnolence (2-3%)
Frequency Not Defined
Diarrhea, Nausea, Gynecomastia, Galactorrhea, Impotence, Neuroleptic malignant syndrome, Menstrual disorders, Hematologic abnormalities
Potentially Fatal:
Neuroleptic malignant syndrome;
Cardiac conduction disorders may occur with IV dosage form.
Mechanism of Action
Metoclopramide enhances the motility of the upper GI tract and increases gastric emptying without affecting gastric, biliary or pancreatic secretions. It increases duodenal peristalsis which decreases intestinal transit time, and increases lower oesophageal sphincter tone. It is also a potent central dopamine-receptor antagonist and may also have serotonin-receptor (5-HT3) antagonist properties.
Note
Premosan 10mg Tablets manufactured by Julphar (Gulf Pharmaceutical Industries). Its generic name is Metoclopramide Hydrochloride. Premosan is availble in United Arab Emirates.
Farmaco UAE drug index information on Premosan Tablets is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.
Some other brands of Metoclopramide Hydrochloride :
Syrup
Riamide
5mg/5ml
Riyadh Pharma (Medical and Cosmetic Products Company Ltd.)
Tablets
Pylomid
10mg
The Jordanian Pharmaceutical Manufacturing Company
Syrup
Premosan
5mg/5ml
Julphar (Gulf Pharmaceutical Industries)
Injection
Premosan
10mg/2ml
Julphar (Gulf Pharmaceutical Industries)
Drops (Oral)
Premosan
4mg/ml
Julphar (Gulf Pharmaceutical Industries)