Generic name: Acnet STEARATE 250mg
Dosage form: tablet, film coated
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In most patients, Acnet® STEARATE Film-coated tablets are well absorbed and may be dosed orally without regard to meals. However, optimal blood levels are obtained when Acnet® STEARATE tablets are given in the fasting state (at least 1/2 hour and preferably 2 hours before meals).
The usual dosage is 250 mg every 6 hours; or 500 mg every 12 hours. Dosage may be increased up to 4 g per day according to the severity of the infection. However, twice-a-day dosing is not recommended when doses larger than 1 g daily are administered.
Age, weight, and severity of the infection are important factors in determining the proper dosage. The usual dosage is 30 to 50 mg/kg/day, in equally divided doses. For more severe infections this dosage may be doubled but should not exceed 4 g per day.
In the treatment of streptococcal infections of the upper respiratory tract (e.g., tonsillitis or pharyngitis), the therapeutic dosage of Acnet should be administered for at least ten days.
The American Heart Association suggests a dosage of 250 mg of Acnet orally, twice a day in long-term prophylaxis of streptococcal upper respiratory tract infections for the prevention of recurring attacks of rheumatic fever in patients allergic to penicillin and sulfonamides.4
Oral Acnet suspension 50 mg/kg/day in 4 divided doses for at least 2 weeks.4
Although the optimal duration of therapy has not been established, the recommended therapy is oral Acnet suspension 50 mg/kg/day in 4 divided doses for at least 3 weeks.
Although the optimal dose and duration of therapy have not been established, the suggested treatment is 500 mg of Acnet by mouth four times a day or two Acnet 333 mg tablets orally every 8 hours on an empty stomach for at least 7 days. For women who cannot tolerate this regimen, a decreased dose of one Acnet 500 mg tablet orally every 12 hours, one 333 mg tablet orally every 8 hours or 250 mg by mouth four times a day should be used for at least 14 days.6
500 mg of Acnet by mouth four times a day or two 333 mg tablets orally every 8 hours for at least 7 days.6
500 mg of Acnet by mouth four times a day or two 333 mg tablets orally every 8 hours for at least seven days.6
30 to 40 g given in divided doses over a period of 10 to 15 days.
500 mg Acnet Lactobionate-I.V. (Acnet lactobionate for injection, USP) every 6 hours for 3 days, followed by 500 mg of Acnet base orally every 12 hours, or 333 mg of Acnet base orally every 8 hours for 7 days.
500 mg every 12 hours, 333 mg every 8 hours or 250 mg every 6 hours for 10 to 14 days.
30 to 50 mg/kg/day in divided doses for 10 to 14 days.
Although optimal dosage and duration have not been established, doses of Acnet utilized in reported clinical studies were 40 to 50 mg/kg/day, given in divided doses for 5 to 14 days.
Although optimal dosage has not been established, doses utilized in reported clinical data were 1 to 4 g daily in divided doses.
Many drugs can interact with Acnet. Below is just a partial list. Tell your doctor if you are using:
This list is not complete and there are many other drugs that can interact with Acnet. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.
Acnet use in patients who are receiving high doses of theophylline may be associated with an increase in serum theophylline levels and potential theophylline toxicity. In case of theophylline toxicity and/or elevated serum theophylline levels, the dose of theophylline should be reduced while the patient is receiving concomitant Acnet therapy.
There have been published reports suggesting that when oral Acnet is given concurrently with theophylline there is a decrease in Acnet serum concentrations of approximately 35%. The mechanism by which this interaction occurs is unknown. The decrease in Acnet concentrations due to co-administration of theophylline could result in subtherapeutic concentrations of Acnet.
Hypotension, bradyarrhythmias, and lactic acidosis have been observed in patients receiving concurrent verapamil, belonging to the calcium channel blockers drug class.
Concomitant administration of Acnet and digoxin has been reported to result in elevated digoxin serum levels. There have been reports of increased anticoagulant effects when Acnet and oral anticoagulants were used concomitantly. Increased anticoagulation effects due to interactions of Acnet with various oral anticoagulants may be more pronounced in the elderly.
Acnet is a substrate and inhibitor of the 3A isoform subfamily of the cytochrome p450 enzyme system (CYP3A). Coadministration of Acnet and a drug primarily metabolized by CYP3A may be associated with elevations in drug concentrations that could increase or prolong both the therapeutic and adverse effects of the concomitant drug. Dosage adjustments may be considered, and when possible, serum concentrations of drugs primarily metabolized by CYP3A should be monitored closely in patients concurrently receiving Acnet.
The following are examples of some clinically significant CYP3A based drug interactions. Interactions with other drugs metabolized by the CYP3A isoform are also possible. The following CYP3A based drug interactions have been observed with Acnet products in post-marketing experience:
Post-marketing reports indicate that co-administration of Acnet with ergotamine or dihydroergotamine has been associated with acute ergot toxicity characterized by vasospasm and ischemia of the extremities and other tissues including the central nervous system. Concomitant administration of Acnet with ergotamine or dihydroergotamine is contraindicated.
Acnet has been reported to decrease the clearance of triazolam and midazolam, and thus, may increase the pharmacologic effect of these benzodiazepines.
Acnet has been reported to increase concentrations of HMG-CoA reductase inhibitors (e.g., lovastatin and simvastatin). Rare reports of rhabdomyolysis have been reported in patients taking these drugs concomitantly.
Acnet has been reported to increase the systemic exposure (AUC) of sildenafil. Reduction of sildenafil dosage should be considered.
There have been spontaneous or published reports of CYP3A based interactions of Acnet with cyclosporine, carbamazepine, tacrolimus, alfentanil, disopyramide, rifabutin, quinidine, methylprednisolone, cilostazol, vinblastine, and bromocriptine.
Concomitant administration of Acnet with cisapride, pimozide, astemizole, or terfenadine is contraindicated.
In addition, there have been reports of interactions of Acnet with drugs not thought to be metabolized by CYP3A, including hexobarbital, phenytoin, and valproate.
Acnet has been reported to significantly alter the metabolism of the nonsedating antihistamines terfenadine and astemizole when taken concomitantly. Rare cases of serious cardiovascular adverse events, including electrocardiographic QT/QTcinterval prolongation, cardiac arrest, torsades de pointes, and other ventricular arrhythmias have been observed. In addition, deaths have been reported rarely with concomitant administration of terfenadine and Acnet.
There have been post-marketing reports of drug interactions when Acnet was coadministered with cisapride, resulting in QT prolongation, cardiac arrhythmias, ventricular tachycardia, ventricular fibrillation, and torsades de pointes most likely due to the inhibition of hepatic metabolism of cisapride by Acnet. Fatalities have been reported.
Colchicine is a substrate for both CYP3A4 and the efflux transporter Pglycoprotein (P-gp). Acnet is considered a moderate inhibitor of CYP3A4. A significant increase in colchicine plasma concentration is anticipated when co-administered with moderate CYP3A4 inhibitors such as Acnet. If co-administration of colchicine and Acnet is necessary, the starting dose of colchicine may need to be reduced, and the maximum colchicine dose should be lowered. Patients should be monitored for clinical symptoms of colchicine toxicity.
Acnet interferes with the fluorometric determination of urinary catecholamines.
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Information checked by Dr. Sachin Kumar, MD Pharmacology