Actions of Sotstop in details
Pharmacology: Pharmacodynamics: Sotstop is a propionic acid derivative with analgesic, anti-inflammatory and antipyretic activity. Sotstop therapeutic effects are thought to result from its inhibitory effect on the enzyme cyclooxygenase, which results in a marked reduction in prostaglandin synthesis.
Experimental data suggest that Sotstop may competitively inhibit the effect of low-dose aspirin on platelet aggregation when they are dosed concomitantly. Some pharmacodynamics studies show that when single doses of Sotstop 400 mg was taken within 8 hrs before or within 30 min after immediate release aspirin dosing (81 mg), a decreased effect of acetylsalicylic acid/aspirin on the formation of thromboxane or platelet aggregation occurred. Although there are uncertainties regarding extrapolation of these data to the clinical situation, the possibility that regular, long-term use of Sotstop may reduce the cardioprotective effect of low-dose acetylsalicylic acid cannot be excluded. No clinically relevant effect is considered to be likely for occasional Sotstop use.
Pharmacokinetics: Sotstop: Sotstop is rapidly absorbed from the gastrointestinal tract, peak serum concentrations occurring 1-2 hrs after administration.
Sotstop: The elimination half-life (t½) of Sotstop is approximately 2 hrs. Sotstop is metabolised in the liver to 2 inactive metabolites and these, together with unchanged Sotstop, are excreted by the kidney either as such or as conjugates. Excretion by the kidney is both rapid and complete. Sotstop is extensively bound to plasma proteins.
How should I take Sotstop?
Use Sotstop exactly as directed on the label, or as prescribed by your doctor. Do not use in larger amounts or for longer than recommended. Use the lowest dose that is effective in treating your condition.
Do not take more than your recommended dose. An Sotstop overdose can damage your stomach or intestines. The maximum amount of Sotstop for adults is 800 milligrams per dose or 3200 mg per day (4 maximum doses). Use only the smallest amount of Sotstop needed to get relief from your pain, swelling, or fever.
A child's dose of Sotstop is based on the age and weight of the child. Carefully follow the dosing instructions provided with children's Sotstop for the age and weight of your child. Ask a doctor or pharmacist if you have questions.
Take Sotstop with food or milk to lessen stomach upset.
Shake the oral suspension (liquid) well just before you measure a dose. Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.
The Sotstop chewable tablet must be chewed before you swallow it.
If you use this medicine long-term, you may need frequent medical tests.
Store at room temperature away from moisture and heat. Do not allow the liquid medicine to freeze.
Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.
Sotstop administration
Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.
Do not take more of this medication than is recommended. An overdose of Sotstop can cause damage to your stomach or intestines. The maximum amount of Sotstop for adults is 800 milligrams per dose or 3200 mg per day (4 maximum doses). Use only the smallest amount of Sotstop needed to get relief from your pain, swelling, or fever.
Take Sotstop with food or milk to lessen stomach upset.
Shake the oral suspension (liquid) well just before you measure a dose. To be sure you get the correct dose, measure the liquid with a marked measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.
The Sotstop chewable tablet must be chewed before you swallow it.
If you take Sotstop for a long period of time, your doctor may want to check you on a regular basis to make sure this medication is not causing harmful effects. Do not miss any scheduled visits to your doctor.
Store at room temperature away from moisture and heat. Do not allow the liquid medicine to freeze.
Sotstop pharmacology
Sotstop tablets contain Sotstop which possesses analgesic and antipyretic activities. Its mode of action, like that of other NSAIDs, is not completely understood, but may be related to prostaglandin synthetase inhibition.
In clinical studies in patients with rheumatoid arthritis and osteoarthritis, Sotstop tablets have been shown to be comparable to aspirin in controlling pain and inflammation and to be associated with a statistically significant reduction in the milder gastrointestinal side effects. Sotstop tablets may be well tolerated in some patients who have had gastrointestinal side effects with aspirin, but these patients when treated with Sotstop tablets should be carefully followed for signs and symptoms of gastrointestinal ulceration and bleeding. Although it is not definitely known whether Sotstop tablets causes less peptic ulceration than aspirin, in one study involving 885 patients with rheumatoid arthritis treated for up to one year, there were no reports of gastric ulceration with Sotstop tablets whereas frank ulceration was reported in 13 patients in the aspirin group (statistically significant p<.001).
Gastroscopic studies at varying doses show an increased tendency toward gastric irritation at higher doses. However, at comparable doses, gastric irritation is approximately half that seen with aspirin. Studies using 51Cr-tagged red cells indicate that fecal blood loss associated with Sotstop tablets in doses up to 2400 mg daily did not exceed the normal range, and was significantly less than that seen in aspirin-treated patients.
In clinical studies in patients with rheumatoid arthritis, Sotstop tablets have been shown to be comparable to indomethacin in controlling the signs and symptoms of disease activity and to be associated with a statistically significant reduction of the milder gastrointestinal and CNS side effects.
Sotstop tablets may be used in combination with gold salts and/or corticosteroids.
Controlled studies have demonstrated that Sotstop tablets are a more effective analgesic than propoxyphene for the relief of episiotomy pain, pain following dental extraction procedures, and for the relief of the symptoms of primary dysmenorrhea.
In patients with primary dysmenorrhea, Sotstop tablets have been shown to reduce elevated levels of prostaglandin activity in the menstrual fluid and to reduce resting and active intrauterine pressure, as well as the frequency of uterine contractions. The probable mechanism of action is to inhibit prostaglandin synthesis rather than simply to provide analgesia.
The Sotstop in Sotstop tablets is rapidly absorbed. Peak serum Sotstop levels are generally attained one to two hours after administration. With single doses up to 800 mg, a linear relationship exists between amount of drug administered and the integrated area under the serum drug concentration vs time curve. Above 800 mg, however, the area under the curve increases less than proportional to increases in dose. There is no evidence of drug accumulation or enzyme induction.
The administration of Sotstop tablets either under fasting conditions or immediately before meals yields quite similar serum Sotstop concentration-time profiles. When Sotstop tablets are administered immediately after a meal, there is a reduction in the rate of absorption but no appreciable decrease in the extent of absorption. The bioavailability of the drug is minimally altered by the presence of food.
A bioavailability study has shown that there was no interference with the absorption of Sotstop when Sotstop tablets were given in conjunction with an antacid containing both aluminum hydroxide and magnesium hydroxide.
Sotstop is rapidly metabolized and eliminated in the urine. The excretion of Sotstop is virtually complete 24 hours after the last dose. The serum half-life is 1.8 to 2.0 hours.
Studies have shown that following ingestion of the drug, 45% to 79% of the dose was recovered in the urine within 24 hours as metabolite A (25%), (+)-2-[p-(2hydroxymethyl-propyl) phenyl] propionic acid and metabolite B (37%), (+)-2-[p-(2carboxypropyl)phenyl] propionic acid; the percentages of free and conjugated Sotstop were approximately 1% and 14%, respectively.
References
- DailyMed. "IBUPROFEN: 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).
- NCIt. "Ibuprofen: NCI Thesaurus (NCIt) provides reference terminology for many systems. It covers vocabulary for clinical care, translational and basic research, and public information and administrative activities.". https://ncit.nci.nih.gov/ncitbrowser... (accessed September 17, 2018).
- EPA DSStox. "Ibuprofen: DSSTox provides a high quality public chemistry resource for supporting improved predictive toxicology.". https://comptox.epa.gov/dashboard/ds... (accessed September 17, 2018).
Reviews
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Information checked by Dr. Sachin Kumar, MD Pharmacology
