What happens if I overdose Ultac?
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local, or emergency room immediately. Symptoms may include dizziness; trouble walking.
Proper storage of Ultac tablets:
Store Ultac tablets at room temperature, between 68 and 77 degrees (20 and 25 degrees C), in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Ultac tablets out of the reach of children and away from pets.
Overdose of Ultac in details
There has been virtually no experience with overdosage with Ultac Injection and limited experience with oral doses of Ultac. Reported acute ingestions of up to 18 g orally have been associated with transient adverse effects similar to those encountered in normal clinical experience. In addition, abnormalities of gait and hypotension have been reported.
When overdosage occurs, clinical monitoring and supportive therapy should be employed.
Studies in dogs receiving dosages of Ultac hydrochloride in excess of 225 mg/kg/day have shown muscular tremors, vomiting, and rapid respiration. Single oral doses of 1,000 mg/kg in mice and rats were not lethal.
Intravenous LD50 values in mice and rats were 77 and 83 mg/kg, respectively.
What should I avoid while taking Ultac?
Avoid drinking alcohol. It can increase the risk of damage to your stomach.
Ultac warnings
With careful use in patients with impaired renal excretory function.
Before treatment with Ultac Dong-il is necessary to exclude the possibility of a malignant disease of the esophagus, stomach or duodenum.
With long-term treatment of debilitated patients under stress conditions may be bacterial lesions of the stomach with subsequent spread of infection.
Undesirable abrupt discontinuation of Ultac because of the risk of recurrence of peptic ulcer. Effectiveness of prophylactic treatment of peptic ulcer above while taking Ultac courses for 45 days in spring and autumn than during the reception. Quick intravenous injection of Ultac in rare cases cause bradycardia, usually in patients predisposed to cardiac arrhythmias.
There are a few reports that Ultac might contribute to the development of acute attacks of porphyria, in connection with what is necessary to avoid its use in patients with acute porphyria in history.
Therapy with Ultac possible distortions of laboratory data: increased creatinine, the activity of gamma-glutamyl transpeptidase and liver transaminases in the blood plasma.
In cases where Ultac is used in combination with antacids, the break between taking antacids and Ultac should be at least 1-2 hours (antacids may cause undesired absorption of Ultac).
Clinical data on the safety of Ultac in pediatric patients is limited.
What should I discuss with my healthcare provider before taking Ultac?
Some medical conditions may interact with Ultac effervescent tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have a history of kidney or liver problems
- if you have phenylketonuria
Some MEDICINES MAY INTERACT with Ultac effervescent tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Certain benzodiazepines (eg, midazolam, triazolam), glipizide, procainamide, or warfarin because the risk of their side effects may be increased by Ultac effervescent tablets
- Dasatinib, delavirdine, gefitinib, certain HIV protease inhibitors (eg, atazanavir), itraconazole, or ketoconazole because their effectiveness may be decreased by Ultac effervescent tablets
This may not be a complete list of all interactions that may occur. Ask your health care provider if Ultac effervescent tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
Ultac precautions
General:
-
1. Symptomatic response to therapy with Ultac Tablets, USP does not preclude the presence of gastric malignancy.
-
2.Since Ultac is excreted primarily by the kidney, dosage should be adjusted in patients with impaired renal function. Caution should be observed in patients with hepatic dysfunction since Ultac is metabolized in the liver.
-
3.Rare reports suggest that Ultac may precipitate acute porphyric attacks in patients with acute porphyria. Ultac Tablets, USP should therefore be avoided in patients with a history of acute porphyria.
Laboratory Tests: False-positive tests for urine protein with MULTISTIX® may occur during therapy with Ultac Tablets, USP therapy, and therefore testing with sulfosalicylic acid is recommended.
Drug Interactions: Ultac Tablets, USP has been reported to affect the bioavailability of other drugs
through several different mechanisms such as competition for renal tubular secretion, alteration of gastric pH, and
inhibition of cytochrome P450 enzymes.
Procainamide: Ultac, a substrate of the renal organic cation transport system, may affect the clearance of
other drugs eliminated by this route. High doses of Ultac (e.g., such as those used in the treatment of
Zollinger-Ellison syndrome) have been shown to reduce the renal excretion of procainamide and
N-acetylprocainamide resulting in increased plasma levels of these drugs. Although this interaction is unlikely to
be clinically relevant at usual Ultac doses, it may be prudent to monitor for procainamide toxicity when
administered with oral Ultac at a dose exceeding 300 mg per day.
Warfarin: There have been reports of altered prothrombin time among patients on concomitant warfarin and
Ultac therapy. Due to the narrow therapeutic index, close monitoring of increased or decreased prothrombin
time is recommended during concurrent treatment with Ultac.
Ultac may alter the absorption of drugs in which gastric pH is an important determinant of bioavailability.
This can result in either an increase in absorption (e.g., triazolam, midazolam, glipizide) or a decrease in
absorption (e.g., ketoconazole, atazanavir, delavirdine, gefitinib). Appropriate clinical monitoring is
recommended.
Atazanavir: Atazanavir absorption may be impaired based on known interactions with other agents that increase
gastric pH. Use with caution. See atazanavir label for specific recommendations.
Delavirdine: Delavirdine absorption may be impaired based on known interactions with other agents that increase
gastric pH. Chronic use of H2-receptor antagonists with delavirdine is not recommended.
Gefitinib: Gefitinib exposure was reduced by 44% with the co-administration of Ultac and sodium bicarbonate
(dosed to maintain gastric pH above 5.0). Use with caution.
Glipizide: In diabetic patients, glipizide exposure was increased by 34% following a single 150-mg dose of oral
Ultac. Use appropriate clinical monitoring when initiating or discontinuing Ultac.
Ketoconazole:
Oral ketoconazole exposure was reduced by up to 95% when oral Ultac was co-administered in
a regimen to maintain a gastric pH of 6 or above. The degree of interaction with usual dose of Ultac (150
mg twice daily) is unknown.
Midazolam:
Oral midazolam exposure in 5 healthy volunteers was increased by up to 65% when administered
with oral Ultac at a dose of 150 mg twice daily. However, in another interaction study in 8 volunteers
receiving IV midazolam, a 300 mg oral dose of Ultac increased midazolam exposure by about 9%. Monitor
patients for excessive or prolonged sedation when Ultac is co-administered with oral midazolam.
Triazolam: Triazolam exposure in healthy volunteers was increased by approximately 30% when administered
with oral Ultac at a dose of 150 mg twice daily. Monitor patients for excessive or prolonged sedation.
Carcinogenesis, Mutagenesis, Impairment of Fertility: There was no indication of tumorigenic or carcinogenic effects in life-span studies in mice and rats at dosages up to 2,000 mg/kg/day.
Ultac was not mutagenic in standard bacterial tests (Salmonella, Escherichia coli) for mutagenicity at concentrations up to the maximum recommended for these assays. In a dominant lethal assay, a single oral dose of 1,000 mg/kg to male rats was without effect on the outcome of 2 matings per week for the next 9 weeks.
Pregnancy: Teratogenic Effects: Pregnancy Category B. Reproduction studies have been performed in rats and rabbits at doses up to 160 times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to Ultac Tablets, USP. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Nursing Mothers: Ultac is secreted in human milk. Caution should be exercised when Ultac Tablets, USP are administered to a nursing mother.
Pediatric Use: The safety and effectiveness of Ultac Tablets, USP have been established in the age-group of 1 month to 16 years for the treatment of duodenal and gastric ulcers, gastroesophageal reflux disease and erosive esophagitis, and the maintenance of healed duodenal and gastric ulcer. Use of Ultac Tablets, USP in this age-group is supported by adequate and well-controlled studies in adults, as well as additional pharmacokinetic data in pediatric patients and an analysis of the published literature.
Safety and effectiveness in pediatric patients for the treatment of pathological hypersecretory conditions or the maintenance of healing of erosive esophagitis have not been established.
Safety and effectiveness in neonates (less than 1 month of age) have not been established
Geriatric Use: Of the total number of subjects enrolled in US and foreign controlled clinical trials of oral formulations of Ultac Tablets, USP, for which there were subgroup analyses, 4,197 were 65 and over, while 899 were 75 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
This drug is known to be substantially excreted by the kidney and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, caution should be exercised in dose selection, and it may be useful to monitor renal function.
What happens if I miss a dose of Ultac?
Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
References
- DrugBank. "ranitidine". http://www.drugbank.ca/drugs/DB00863 (accessed September 17, 2018).
- MeSH. "Histamine H2 Antagonists". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).
Reviews
Consumer reviews
There are no reviews yet. Be the first to write one! |
Information checked by Dr. Sachin Kumar, MD Pharmacology
