Index
Contains diazepam as an active ingredient. It works by increasing the activity of gamma aminobutyric acid in the brain.
Unival is used for the adjunctive treatment of seizures, the treatment of anxiety disorder, the relief of alcohol withdrawal symptoms , the adjunct treatment of muscle spasms, and other conditions.
It is used to treat duodenal and gastric ulcers, gastric ulcers caused by the use of non-steroidal anti-inflammatory drugs, erosive esophagitis, and gastroesophageal reflux disease (GERD).
Unival is available both over the counter (OTC) and with your doctor’s prescription. Unival is used to treat persistent and frequent heartburn.
Unival is a proton pump inhibitor that prevents the stomach from producing acid.
Description of the Unival
Unival is a complex of α-D-glucopyranoside, β-D-fructofuranosyl, octakis (hydrogen sulfate) and aluminum.
- R = SO Al (OH) 3 2.
Tablets for oral administration contain 1 g of Unival. It is manufactured by TAP Pharmaceutical Products. Unival has been in the market for many years and is one of several proton pump inhibitors available.
Clinical pharmacology
Unival is minimally absorbed from the gastrointestinal tract. The small amounts of sulfated disaccharide that are absorbed are excreted mainly in the urine.
Although the mechanism of sucralfate’s ability to accelerate duodenal ulcer healing has yet to be fully defined, it is known to exert its effect through local rather than systemic action. The following observations also seem pertinent:
Studies in human subjects and animal models of ulcer disease have shown that Unival forms an ulcer-adherent complex with proteinaceous exudate at the ulcer site.
A sucralfate-albumin shell provides a barrier to hydrogen ion diffusion.
In human subjects, Unival administered in doses recommended for ulcer therapy inhibits the activity of pepsin in gastric juice by 32%. The Unival absorbs bile salts.
These observations suggest that the antiulcer activity of sucralfate is the result of the formation of an ulcer-adherent complex that covers the ulcer site and protects it against further attacks from acid, pepsin, and bile salts.
There is approximately 14 to 16 mEq of acid neutralizing capacity per 1 gram dose of Unival.
Uses of the Unival
Unival is used in the treatment, control, prevention and improvement of the following diseases, conditions and symptoms:
- Adjunct treatment for seizures.
- Management of anxiety disorder.
- Relief of alcohol withdrawal symptoms.
- Adjunct treatment for muscle spasms.
The Unival is indicated in:
Short-term treatment of active duodenal ulcer
Short-term treatment (up to 8 weeks) of active duodenal ulcer. Unival and Unival delayed-release tablets (orally disintegrating tablets) are indicated for short-term treatment (for 4 weeks) for healing and symptomatic relief of active duodenal ulcer.
While healing with Unival can occur during the first week or two, treatment should be continued for 4 to 8 weeks unless healing has been demonstrated by radiography or endoscopic examination.
Eradication of H. pylori to reduce the risk of duodenal ulcer recurrence
Triple therapy : lansoprazole (unival)/amoxicillin/clarithromycin
Unival and Unival delayed-release tablets in combination with amoxicillin plus clarithromycin as triple therapy.
They are indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active history or one year of duodenal ulcer) to eradicate H. pylori.
Dual therapy : lansoprazole (unival)/amoxicillin
The Unival and Unival delayed-release tablets in combination with amoxicillin as dual therapy.
They are indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or one year history of duodenal ulcer) who are allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected.
Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence in both therapies (triple and dual).
Maintenance of healed duodenal ulcers
Unival and Unival delayed-release tablets are indicated to maintain healing of duodenal ulcers.
Short-term treatment of active benign gastric ulcer
Unival tablets are indicated for short-term treatment (up to 8 weeks) for the healing and relief of symptoms of active benign gastric ulcer.
Nonsteroidal anti-inflammatory drug cure: associated gastric ulcer
Unival simple and delayed-release is indicated for the treatment of gastric ulcer associated with non-steroidal anti-inflammatory drugs in patients who continue to use non-steroidal anti-inflammatory drugs.
Risk reduction of non-steroidal anti-inflammatory drugs: associated gastric ulcer
Unival and Unival delayed-release tablets are indicated to reduce the risk of gastric ulcers associated with non-steroidal anti-inflammatory drugs in patients with a history of documented gastric ulcer requiring the use of a non-steroidal anti-inflammatory drug.
Gastroesophageal Reflux Disease (GERD)
Short-term treatment of symptomatic gastroesophageal reflux disease
Unival and Unival delayed release are indicated for the treatment of heartburn and other symptoms associated with gastroesophageal reflux disease.
Short-term treatment of erosive esophagitis
Both presentations of Unival (Unival simple and delayed release), are indicated for short-term treatment (up to 8 weeks) for the cure and relief of symptoms of all grades of erosive esophagitis.
For patients who are not cured with Unival or Unival delayed-release oral disintegration tablets for 8 weeks (5-10%), an additional 8 weeks of treatment may be helpful.
If there is a recurrence of erosive esophagitis, an additional 8-week cycle of Unival or Unival delayed-release orally disintegrating tablets may be considered.
Maintenance of healing of erosive esophagitis (EE)
Both forms of Unival are indicated to maintain the healing of erosive esophagitis. The analyzes of the clinical trials were not extended beyond 12 months.
Pathological hypersecretory conditions including Zollinger-Ellison syndrome (ZES)
Unival tablets and its other form (Unival orally disintegrating tablets) are indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome.
The Unival can also be used for purposes not mentioned here.
How to take Unival
Take Unival by mouth on an empty stomach before eating. Swallow the Unival tablet whole. Do not break, crush, or chew the tablet before swallowing.
If you cannot swallow the capsule whole, you can open it and sprinkle the contents over 1 tablespoon (15 ml) of applesauce.
Swallow the mixture right away. Do not crush or chew the medicine before swallowing it. Do not store the mixture for future use. DO NOT mix Unival with other foods.
You can also open the capsule and sprinkle the contents in 2 oz (60 ml) of apple juice, orange juice, or tomato juice. Mix briefly, then swallow all at once.
Do not chew or crush the granules. Do not save the mixture for later use. After taking your dose, rinse the glass with at least 4 ounces (120 ml) of juice and swallow to make sure you have received all of the medicine. DO NOT mix Unival with other liquids.
If the patient is taking Unival through a nasogastric (NG) tube, follow the instructions for use in the additional patient leaflet. You can take antacids while using Unival if your doctor tells you to.
Keep taking Unival even if you feel fine. Ask your healthcare provider any questions you have about how to use Unival.
Unival dosage
Unival and Unival delayed-release tablets (orally disintegrating tablets) are available in 15 mg and 30 mg strengths.
Route specific directions for use and methods of administration available for each of these dosage forms are presented below.
Recommended dose in special populations
Patients with renal insufficiency and geriatric patients do not require dose adjustment. However, consider adjusting the dose in patients with severe hepatic impairment.
Unival overdose
If you suspect that you or someone else may have overdosed Unival, go to the emergency department of the nearest hospital or nursing home.
Due to limited human experience with Unival overdose, no specific treatment recommendations can be given. Acute oral toxicity studies in animals, however, at doses up to 12 g / kg body weight, could not find a lethal dose.
Unival is minimally absorbed from the gastrointestinal tract. The risks associated with acute overdose should, therefore, be minimal. In rare reports describing Unival overdose, the majority of patients remained asymptomatic.
The few reports in which adverse events were described included symptoms of dyspepsia, abdominal pain, nausea, and vomiting.
Unival metabolization
Unival is metabolized through the cytochrome P450 system, specifically through the isoenzymes CYP3A and CYP2C19.
Studies have shown that Unival has no clinically significant interactions with other drugs metabolized by the cytochrome P450 system, such as warfarin, antipyrine, indomethacin, ibuprofen, phenytoin, propranolol, prednisone, diazepam, clarithromycin, or terfenadine in healthy subjects.
These compounds are metabolized by various cytochrome P450 isoenzymes, including CYP1A2, CYP2C9, CYP2C19, CYP2D6, and CYP3A.
When Unival was co-administered with theophylline (CYP1A2, CYP3A), a minor (10%) increase in theophylline clearance was observed.
Due to the small magnitude and direction of the effect on theophylline clearance, this interaction is unlikely to be a clinical concern.
However, individual patients may require further titration of their theophylline dose when starting or stopping Unival to ensure clinically effective blood levels.
Unival has also been shown not to have a clinically significant interaction with amoxicillin.
In a single-dose crossover study examining Unival 30 mg and omeprazole 20 mg each administered alone and concomitantly with Unival 1 gram, the absorption of proton pump inhibitors was delayed and their bioavailability was reduced by 17% and 16%. , respectively, when administered concomitantly with Unival.
Therefore, proton pump inhibitors should be taken at least 30 minutes before Unival. In clinical trials, antacids were administered concomitantly with Unival; this did not interfere with its effect.
The Unival causes a deep and lasting inhibition of gastric acid secretion; therefore, it is theoretically possible that Unival may interfere with the absorption of drugs in which gastric pH is an important determinant of bioavailability (eg, ketoconazole, ampicillin esters, iron salts, digoxin).
Side effects
Drowsiness, fatigue, muscle weakness, ataxia, confusion, depression, dysarthria, headache, fluent speech, tremor.
Unival can also cause side effects not mentioned here.
Side effects found in clinical trials
Worldwide, more than 10,000 patients have been treated with Unival in Phase 2 or Phase 3 clinical trials involving various doses and durations of treatment.
In general, treatment with Unival has been well tolerated in both short-term and long-term trials.
Because clinical trials are conducted under highly variable conditions, the rates of adverse reactions seen in clinical trials of one drug cannot be directly compared to rates in clinical trials of another drug and may not reflect the rates seen in the drug. clinical practice.
The following adverse reactions were reported by the treating physician to have a possible or probable relationship to the drug in 1% or more of lansoprazole-treated patients and occurred more frequently in lansoprazole-treated patients than in placebo-treated patients.
Headache was also seen with an incidence greater than 1%, but was more common with placebo.
The incidence of diarrhea was similar between patients receiving placebo and patients receiving Unival 15 mg and 30 mg, but higher in patients receiving Unival 60 mg (2.9%, 1.4%, 4.2 % and 7.4%, respectively).
The possibly most frequent or likely treatment-related adverse event reported during maintenance therapy was diarrhea.
In Unival’s risk reduction study for NSAID-associated gastric ulcers, the incidence of diarrhea in patients treated with Unival, misoprostol, and placebo was 5%, 22%, and 3%, respectively.
Another study for the same indication, where patients took a COX-2 inhibitor or Unival and naproxen, showed that the safety profile was similar to that of the previous study.
Additional reactions from this study not previously observed in other clinical trials with Unival included contusion, duodenitis, epigastric discomfort, esophageal disorder, fatigue, hunger, hiatal hernia, hoarseness, impaired gastric emptying, metaplasia, and renal failure.
Side effects during the clinical trial
Additional adverse experiences occurring in less than 1% of patients or subjects who received Unival in national trials are shown below:
Body in general : enlarged abdomen, allergic reaction, asthenia, back pain, candidiasis, carcinoma, chest pain (not specified), chills, edema, fever, flu syndrome, halitosis, infection (not otherwise specified), general malaise , neck pain, stiff neck, pain, pelvic pain.
Cardiovascular system : angina, arrhythmia, bradycardia, cerebrovascular accident / cerebral infarction, hypertension / hypotension, migraine, myocardial infarction, palpitations, shock (circulatory failure), syncope, tachycardia, vasodilation.
Digestive system : abnormal stools, anorexia, bezoar, cardiospasm, cholelithiasis, colitis, dry mouth, dyspepsia, dysphagia, enteritis, belching, esophageal stricture, esophageal ulcer.
Also Esophagitis, fecal discoloration, flatulence, gastric nodules / fundic gland polyps, gastritis, gastroenteritis, gastrointestinal abnormality, gastrointestinal disorder, gastrointestinal bleeding, glossitis, bleeding gums, hematemesis, increased appetite.
Also increased salivation, melena, mouth ulceration, nausea and vomiting, nausea and vomiting and diarrhea, gastrointestinal moniliasis, rectal disorder, rectal bleeding, stomatitis, tenesmus, thirst, tongue disorder, ulcerative colitis, ulcerative stomatitis
Endocrine system : diabetes mellitus, goiter, hypothyroidism.
Hematic and lymphatic system : anemia, hemolysis, lymphadenopathy.
Metabolic and nutritional disorders : vitamin deficiency, gout, dehydration, hyperglycemia / hypoglycemia, peripheral edema, weight gain / loss
Musculoskeletal system : arthralgia, arthritis, bone disorders, joint disorder, leg cramps, musculoskeletal pain, myalgia, myasthenia, ptosis, synovitis
Nervous system : abnormal dreams, agitation, amnesia, anxiety, apathy, confusion, seizure, dementia, depersonalization, depression, diplopia, dizziness, emotional lability, hallucinations, hemiplegia.
Also aggravated hostility, hyperkinesia, hypertonia, hyperesthesia, insomnia, decreased or increased libido, nervousness, neurosis, paraesthesia, sleep disorder, drowsiness, thought disturbance, tremor, vertigo
Respiratory system : asthma, bronchitis, increased cough, dyspnea, epistaxis, hemoptysis, hiccups, laryngeal neoplasia, pulmonary fibrosis, pharyngitis, pleural disorder, pneumonia, respiratory disorder, upper respiratory infection / inflammation, rhinitis, sinusitis, stridor
Skin and appendages : acne, alopecia, contact dermatitis, dry skin, fixed rash, hair disorder, maculopapular rash, nail disorder, pruritus, rash, skin carcinoma, skin disorder, sweating, hives
Special Senses : abnormal vision, amblyopia, blepharitis, blurred vision, cataracts, conjunctivitis, deafness, dry eyes, ear / eye disorder, eye pain, glaucoma, otitis media, parosmia, photophobia, retinal degeneration / disorder, loss of taste , taste perversion, tinnitus, visual field defect
Urogenital system : abnormal menstruation, breast enlargement, breast pain, breast tenderness, dysmenorrhea, dysuria, gynecomastia, impotence, kidney stone, kidney pain, leukorrhea, menorrhagia, menstrual disorder.
Also penile disorder, polyuria, testicular disorder, urethral pain, urinary frequency urinary retention, urinary tract infection, urinary urgency, difficulty urinating, vaginitis.
Experienced Post-Marketing Side Effects
Additional adverse experiences have been reported since Unival and Unival delayed-release tablets (orally disintegrating tablets) were marketed.
Most of these cases are of foreign origin and a relationship with Unival oral tablets and their delayed-release presentation has not been established.
Because these reactions were reported voluntarily from a population of unknown size, estimates of the frequency cannot be made. These events are listed below:
Body as a whole : anaphylactic / anaphylactoid reactions.
Digestive system : hepatotoxicity, pancreatitis, vomiting.
Hematic and lymphatic system : agranulocytosis, aplastic anemia, hemolytic anemia, leukopenia, neutropenia, pancytopenia, thrombocytopenia, and thrombotic thrombocytopenic purpura.
Musculoskeletal system : bone fracture, myositis.
Skin and appendages : severe dermatological reactions including erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (some fatal).
Special senses : speech disorder.
Urogenital system : interstitial nephritis, urinary retention.
Effects found during combination therapy with amoxicillin and clarithromycin
In clinical trials using combination therapy of Unival plus amoxicillin and clarithromycin and Unival plus amoxicillin, no adverse reactions associated with these drug combinations were observed.
The adverse reactions that have occurred have been limited to those previously reported with Unival, amoxicillin or clarithromycin.
Triple therapy : lansoprazole (unival)/amoxicillin/clarithromycin.
The most frequently reported adverse reactions for patients receiving triple therapy for 14 days were diarrhea (7%), headache (6%), and taste perversion (5%).
There were no statistically significant differences in the frequency of reported adverse reactions between the 10 and 14 day triple therapy regimens.
No treatment-emergent adverse reactions were observed at significantly higher rates with triple therapy than with any dual therapy regimen.
Precautions when using Unival
Abrupt withdrawal of Valium. Avoid driving. Avoid simultaneous ingestion of alcohol and other central nervous system depressant drugs.
Concomitant use with anticonvulsant medication. Check with your doctor if you plan to abruptly stop this drug. Check with your doctor if you plan to adjust the dose.
Weakened patients. History of alcohol or drug abuse. Psychotic patients. Severely depressed patients.
This can increase your risk of side effects or make your medicine not work properly.
Duodenal ulcer is a chronic recurrent disease.
While short-term treatment with Unival may result in complete healing of the ulcer, a successful course of treatment with Unival should not be expected to alter the frequency or severity of duodenal ulceration after healing.
Adverse reactions to Unival in clinical trials were minor and only rarely led to discontinuation of the drug. In studies with more than 2,700 patients treated with Unival tablets, adverse effects were reported in 129 (4.7%).
Constipation was the most frequent complaint (2%). Other adverse effects reported in less than 0.5% of patients.
Unival interactions
Unival may interact with the following drugs and products:
- Alcohol, anesthetics, antacids, anticonvulsant drugs, antidepressant drugs, antipsychotics, anxiolytics, barbiturates, central nervous system depressant drugs, cimetidine.
Special populations
Some studies have shown that the simultaneous simultaneous administration in healthy volunteers reduces the degree of absorption of single doses of the following drugs:
- Cimetidine, digoxin, fluoroquinolone antibiotics, ketoconazole, l-thyroxine, phenytoin, quinidine, ranitidine, tetracycline, and theophylline.
Subtherapeutic prothrombin times with concomitant warfarin and Unival therapy have been reported in published and spontaneous case reports.
However, two clinical studies have shown no changes in serum warfarin concentration or prothrombin time with the addition of Unival to chronic warfarin therapy.
The mechanism of these interactions appears to be non-systemic in nature, presumably as a result of the binding of Unival to the concomitant agent in the gastrointestinal tract.
In all case studies to date (cimetidine, ciprofloxacin, digoxin, norfloxacin, ofloxacin, and ranitidine), dosing of concomitant medication 2 hours before unival eliminated the interaction.
Due to the potential of Unival to alter the absorption of some drugs, Unival should be administered separately from other drugs when alterations in bioavailability are considered critical.
In these cases, patients must be properly monitored.
Chronic 24-month oral toxicity studies were performed in mice and rats at doses up to 1 g / kg (12 times the human dose).
There was no evidence of drug-related tumorigenicity. A reproduction study in rats at doses up to 38 times the human dose did not reveal any indication of impaired fertility. Mutagenicity studies were not performed.
Nursing Mothers : It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Unival is administered to a nursing woman.
Unival contraindications
Pediatric patients under 6 months of age, severe liver failure, severe respiratory failure, sleep apnea syndrome.
Can Unival be used for the adjunctive treatment of seizures and the treatment of anxiety disorder?
Yes, adjunct treatment for seizures and treatment for anxiety disorder are among the most common reported uses for Unival.
Do not use Unival for the add-on treatment of seizures and the treatment of anxiety disorder without first consulting your doctor.
