Pantocar to reduce stomach ac >About Pantocar
The active ingredient in PROTONIX (Pantocar sodium) For Delayed-Release Oral Suspension and PROTONIX (Pantocar sodium) Delayed-Release Tablets, a PPI, is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2- sulfinyl]-1H-benzimidazole sesquihydrate, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F2N3NaO4S x 1.5 H2O, with a molecular weight of 432.4. The structural formula is:
Pantocar sodium sesquihydrate is a white to off-white crystalline powder and is racemic. Pantocar has weakly basic and acidic properties. Pantocar sodium sesquihydrate is freely soluble in water, very slightly soluble in phosphate buffer at pH 7.4, and practically insoluble in n-hexane.
The stability of the compound in aqueous solution is pH-dependent. The rate of degradation increases with decreasing pH. At ambient temperature, the degradation half-life is approximately 2.8 hours at pH 5 and approximately 220 hours at pH 7.8.
PROTONIX is supplied as a for delayed-release oral suspension in unit dose packets, available in one strength (40 mg) Pantocar, (equivalent to 45.1 mg of Pantocar sodium), and as a delayed-release tablet, available in two strengths 20 mg Pantocar (equivalent to 22.56 mg of Pantocar sodium) and 40 mg Pantocar (equivalent to 45.1 mg of Pantocar sodium).
PROTONIX Delayed-Release Tablets contain the following inactive ingredients: calcium stearate, crospovidone, hypromellose, iron oxide, mannitol, methacrylic acid copolymer, polysorbate 80, povidone, propylene glycol, sodium carbonate, sodium lauryl sulfate, titanium dioxide, and triethyl citrate. PROTONIX Delayed-Release Tablets (40 mg and 20 mg) complies with USP dissolution test 2.
PROTONIX For Delayed-Release Oral Suspension contains the following inactive ingredients: crospovidone, hypromellose, methacrylic acid copolymer, microcrystalline cellulose, polysorbate 80, povidone, sodium carbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate, and yellow ferric oxide.
Carcinogenesis, Mutagenesis, Impairment Of Fertility
In a 24-month carcinogenicity study, Sprague-Dawley rats were treated orally with Pantocar doses of 0.5 to 200 mg/kg/day, about 0.1 to 40 times the exposure on a body surface area basis of a 50 kg person dosed with 40 mg/day. In the gastric fundus, treatment at 0.5 to 200 mg/kg/day produced enterochromaffin-like (ECL) cell hyperplasia and benign and malignant neuroendocrine cell tumors in a dose-related manner. In the forestomach, treatment with 50 and 200 mg/kg/day (about 10 and 40 times the recommended human dose on a body surface area basis) produced benign squamous cell papillomas and malignant squamous cell carcinomas. Rare gastrointestinal tumors associated with Pantocar treatment included an adenocarcinoma of the duodenum with 50 mg/kg/day and benign polyps and adenocarcinomas of the gastric fundus with 200 mg/kg/day. In the liver, treatment at 0.5 to 200 mg/kg/day produced dose-related increases in the incidences of hepatocellular adenomas and carcinomas. In the thyroid gland, treatment with 200 mg/kg/day produced increased incidences of follicular cell adenomas and carcinomas for both male and female rats.
In a 24-month carcinogenicity study, Fischer 344 rats were treated orally with doses of 5 to 50 mg/kg/day of Pantocar, approximately 1 to 10 times the recommended human dose based on body surface area. In the gastric fundus, treatment with 5 to 50 mg/kg/day produced enterochromaffin-like (ECL) cell hyperplasia and benign and malignant neuroendocrine cell tumors. Dose selection for this study may not have been adequate to comprehensively evaluate the carcinogenic potential of Pantocar.
In a 24-month carcinogenicity study, B6C3F1 mice were treated orally with doses of 5 to 150 mg/kg/day of Pantocar, 0.5 to 15 times the recommended human dose based on body surface area. In the liver, treatment with 150 mg/kg/day produced increased incidences of hepatocellular adenomas and carcinomas in female mice. Treatment with 5 to 150 mg/kg/day also produced gastric-fundic ECL cell hyperplasia.
A 26-week p53 +/- transgenic mouse carcinogenicity study was not positive.
Pantocar was positive in the in vitro human lymphocyte chromosomal aberration assays, in one of two mouse micronucleus tests for clastogenic effects, and in the in vitro Chinese hamster ovarian cell/HGPRT forward mutation assay for mutagenic effects. Equivocal results were observed in the in vivo rat liver DNA covalent binding assay. Pantocar was negative in the in vitro Ames mutation assay, the in vitro unscheduled DNA synthesis (UDS) assay with rat hepatocytes, the in vitro AS52/GPT mammalian cell-forward gene mutation assay, the in vitro thymidine kinase mutation test with mouse lymphoma L5178Y cells, and the in vivo rat bone marrow cell chromosomal aberration assay.
There were no effects on fertility or reproductive performance when Pantocar was given at oral doses up to 500 mg/kg/day in male rats (98 times the recommended human dose based on body surface area) and 450 mg/kg/day in female rats (88 times the recommended human dose based on body surface area).
Getting the most from your treatment
- Try to keep your regular appointments with your doctor. This is so your progress can be checked. If you are taking Pantocar on a long-term basis your doctor will want to review your treatment at least once a year to make sure it is still right for you.
- A typical course of treatment lasts for one or two weeks if you are taking Pantocar for Helicobacter pylori eradication. It will last for one or two months if it is to allow an ulcer to heal. For all other reasons for taking Pantocar, your treatment will last for as long as is necessary to control your symptoms.
- Some foods may make your symptoms worse. Foods and drinks that have been suspected of this include peppermint, tomatoes, chocolate, spicy foods, hot drinks, coffee, and alcoholic drinks. If it seems that a food is aggravating your symptoms, try avoiding it for a while to see if your symptoms improve. Also, try avoiding eating large meals, as these can make your symptoms worse too.
- If you are overweight, it puts extra pressure on your stomach and encourages the symptoms of acid reflux. Losing some weight and eating a healthy balanced diet may help you.
- Smoking increases the amount of acid produced by the stomach and may make your symptoms worse. If you are a smoker, speak with your doctor or pharmacist about how to quit.
- Recent studies suggest that there may be a slight increase in the risk of bone fractures when proton pump inhibitors like Pantocar are taken for longer than a year. If this affects you, your doctor will check that you are taking enough vitamin D and calcium to reduce this risk.
- If you buy any medicines 'over the counter', always check with a pharmacist that they are safe to take alongside your other medicines.
When treating chronic conditions such as Zollinger–Ellison syndrome, people should take 40 mg of Pantocar twice per day.
Most people tolerate Pantocar well, but some may experience the following side effects:
When people use Pantocar for long periods, they are at an increased risk of the following side effects:
- Clostridium difficile diarrhea
- overgrowth of bacteria in the small intestine
- bone loss
- kidney disorders
People who take Pantocar for an extended period of time are at risk of the drug becoming carcinogenic and causing rare types of gastrointestinal tumors.
Based on a recent major change to its prescribing information, people are also at increased risk of stomach growths called fundic gland polyps when taking PPIs for a long period — especially for longer than 1 year.
Taking Pantocar for extended periods can cause vitamin and mineral deficiencies, such as:
- vitamin B-12 deficiency
- iron deficiency
- calcium deficiency
- magnesium deficiency
Doctors should follow up with people taking Pantocar. After completing the treatment, if a person still has symptoms, the doctors should investigate whether or not the diagnosis was indeed accurate.
Sometimes, people may feel much better after the treatment is complete, but their symptoms may quickly return. Doctors may perform further tests, including an endoscopy.
An endoscopy involves passing a flexible tube with a camera attached, called an endoscope, into the stomach through the mouth to see the inside of the body.
What are the side effects of Protonix?
Pantocar like other PPIs is well tolerated. The most common side effects are:
Rare side effects include:
Other reported side effects include:
High doses and long-term use (1 year or longer) of Pantocar may increase the risk of osteoporosis-related fractures of the hip, wrist, or spine. Therefore, it is important to use the lowest doses and shortest duration of treatment necessary for the condition being treated.
Proton pump inhibitors may increase the risk of Clostridium difficile infection. High doses and long-term use (1 year or longer) may increase the risk of osteoporosis-related fractures of the hip, wrist, or spine. Prolonged use also reduces absorption of vitamin B12 (cyanocobalamin).
Long-term use of PPIs has also been associated with low levels of magnesium (hypomagnesemia). Analysis of patients taking PPIs for long periods showed an increased risk of heart attacks.
Therefore, it is important to use the lowest doses and shortest duration of treatment necessary for the condition being treated.
Pantocar and Magnesium
Low magnesium levels can also occur in people on Pantocar for at least three months.
Tell your doctor if you have ever had low magnesium in your blood or if you have ever tested positive for the bacteria H. pylori.
Low magnesium levels can result in serious adverse events such as:
- Muscle spasms
- Irregular heartbeat
If you have low magnesium levels while using Pantocar, your doctor may advise you to take a magnesium supplement or discontinue treatment.
Pantocar Missed Dose
If you miss a dose of Pantocar, take it as soon as you remember.
You should skip the missed dose if it is almost time for your next scheduled dose.
Don't take extra doses of this drug.
Table 4 includes drugs with clinically important drug interactions and interaction with diagnostics when administered concomitantly with PROTONIX and instructions for preventing or managing them.
Consult the labeling of concomitantly used drugs to obtain further information about interactions with PPIs.
Table 4: Clinically relevant Interactions Affecting Drugs Co-Administered with PROTONIX and Interaction with DiagnosticsAntiretroviralsClinical Impact:The effect of PPIs on antiretroviral drugs is variable. The clinical importance and the mechanisms behind these interactions are not always known.
- Decreased exposure of some antiretroviral drugs (e.g., rilpivirine atazanavir, and nelfinavir) when used concomitantly with PROTONIX may reduce antiviral effect and promote the development of drug resistance.
- Increased exposure of other antiretroviral drugs (e.g., saquinavir) when used concomitantly with PROTONIX may increase toxicity.
- There are other antiretroviral drugs which do not result in clinically relevant interactions with Pantocar sodium.
Will my dose go up or down?
Sometimes your doctor will increase your dose of Pantocar if it isn't working well enough.
Depending on the reason you take Pantocar, you may take a higher dose to begin with, usually for a month or two. After this, your doctor may recommend that you take a lower dose.
How to take Pantocar
- Before you start this treatment, read the manufacturer's printed information leaflet from ins >