MD Anamul Haque

Product Data Sheet Doxofyl Doxofylline Composition Doxofyl 200 Tablet: Each film coated tablet contains 200 mg Doxofylline INN. Doxofyl 400 Tablet: Each film coated tablet contains 400 mg Doxofylline INN. Description Doxofyl (Doxofylline) is a novel bronchodilator. It structurally differs from Theophylline due to the presence of a dioxolane group in position 7. Doxophylline selectively inhibits phophodtasere-4 thereby relaxes bronchial smooth muscle.However, differently from Theophylline, Doxophylline appears to have decreased affinities toward adenosine Al and A2 receptors, which may account for the better safety profile of the drug. Doxophylline is reported to inhibit platelet activating factor (PAF) and generation of leukotriene production. Indications Doxofyl (Doxophylline) is used to treat asthma, COPD and bronchospasm. Dosage & Administration Adults: 400 mg once daily in the evening. On the basis of clinical response the dose may be increased to 3 tablets daily (not more than 1200 mg/daily) Elderly Patients: 200 mg two or three times daily Children (above 6 years of age): 6 mg/kg body weight twice daily, i.e. if bodyweight is 15 kg, 90 mg twice daily. Side Effects Doxophylline rarely causes serious side effects, however possible side effects are similar for taking excess amount of caffeine. These include: nausea, vomiting, headache, upset stomach and heartburn. Precautions The half-life of Xanthine derivatives is influenced by a number of known variables. It may be prolonged in patients with liver disease, in patients with congestive heart failure and in those patients taking certain other drugs like Erythromycin, Troleandomycin, Lincomycin, Allopurinol, Cimetidine, Propanolol and anti-flu vaccine. In these cases, a lower dose of Doxophylline may be needed. Phenytoin , other anticonvulsants and smoking may cause an increase in clearance with a shorter mean half-life. In these cases higher doses of Doxophylline may be needed. Contraindications Doxophylline is contraindicated in acute myocardial infarction. It is also contraindicated in patients with hypotension, in lactating women 8 patients who have shown hypersensitivity to its components. Drug Interactions Doxophylline should not be administered together with other Xanthine derivatives. Toxic synergism with ephedrine has been documented for Xanthines. Like other Xanthenes, concomitant therapy with Troleandomycin, Lincomycin, Allopurinol, Cimetidine, Propanolol and anti-flu vaccine may decrease the hepatic clearance of xanthenes causing an increase in blood levels. No evidence of a relationship between Doxophylline serum concentrations and toxic events have been reported. Use in Pregnancy & Lactation Animal reproduction studies indicate that, Doxophylline does not cause fetal harm when administered to pregnant animals or can not affect reproduction capacity. However, since there is limited experience in human during pregnancy, Xanthines should be given to pregnant women only if clearly needed. Doxophylline is contraindicated in nursing mothers. Storage Condition Keep in a dry place away from light and heat. Keep out of the reach of children. Doxophylline should be used only on prescription of specialist physician. Commercial Pack Doxofyl 200 Tablet: Each box contains 3 X 10 tablets in Alu-Alu blister pack. Doxofyl 400 Tablet: Each box contains 3 X 10 tablets in Alu-Alu blister pack. Doriject Doripenem 500 mg Presentation DorijectTM 500 mg Powder for IV Infusion: Each vial contains sterile Doripenem Monohydrate INN equivalent to 500 mg Anhydrous Doripenem. Description Doripenem monohydrate for injection vials contains 500 mg of Doripenem on an anhydrous basis, a white to slightly-yellowish off-white sterile crystalline powder. All references to doripenem activity are expressed in terms of the active Doripenem moiety. The powder is constituted for intravenous infusion. Doripenem is not formulated with any inactive ingredients. Doripenem is a synthetic broad-spectrum carbapenem antibiotic structurally related to beta-lactam antibiotics. Indications To reduce the development of drug-resistant bacteria and maintain the effectiveness of Doripenem and other antibacterial drugs, Doripenem should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting and modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Complicated Intra-Abdominal Infections Doripenem (Doripenem for injection) is indicated as a single agent for the treatment of complicated intra-abdominal infections caused by Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, Bacteroides caccae, Bacteroides fragilis, Bacteroides thetaiotaomicron, Bacteroides uniformis, Bacteroides vulgatus, Streptococcus intermedius, Streptococcus constellatus and Peptostreptococcus micros. Complicated Urinary Tract Infections, Including Pyelonephritis Doripenem (Doripenem for injection) is indicated as a single agent for the treatment of complicated urinary tract infections, including pyelonephritis caused by Escherichia coli including cases with concurrent bacteremia, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa and Acinetobacter baumannii. Dosage and Administration The recommended dosage of Doripenem is 500 mg administered every 8 hours by intravenous infusion over one hour in patients >18 years of age. The recommended dosage and administration by infection is described in Table 1: Table 1: Dosage of Doripenem by Infection Infection Dosage Frequency Infusion Time (hours) Duration Complicated intra-abdominal infection 500 mg every 8 hours 1 5–14 days* Complicated UTI, including pyelonephritis 500 mg every 8 hours 1 10 days*† * Duration includes a possible switch to an appropriate oral therapy, after at least 3 days of parenteral therapy, once clinical improvement has been demonstrated. † Duration can be extended up to 14 days for patients with concurrent bacteremia. Patients with Renal Impairment Table 2: Dosage of Doripenem in Patients with Renal Impairment Estimated CrCl (mL/min) Recommended Dosage Regimen of doripenem > 50 No dosage adjustment necessary ≥ 30 to ≤ 50 250 mg intravenously (over 1 hour) every 8 hours > 10 to < 30 250 mg intravenously (over 1 hour) every 12 hours Doripenem is hemodialyzable; however, there is insufficient information to make dose adjustment recommendations in patients on hemodialysis. Preparation of Solutions Doripenem does not contain a bacteriostatic preservative. Aseptic technique must be followed in preparation of the infusion solution. Preparation of 500 mg dose: Constitute the vial with 10 mL of sterile water for injection or 0.9% sodium chloride injection (normal saline) and gently shake to form a suspension. The resultant concentration is 50 mg/mL. Withdraw the suspension using a syringe with a 21 gauge needle and add it to an infusion bag containing 100 mL of normal saline or 5% dextrose; gently shake until clear. The final infusion solution concentration is 4.5 mg/mL. Side Effects The following adverse reactions are discussed in greater detail in other sections of labeling: Anaphylaxis and serious hypersensitivity reactions, Seizures, Interaction with sodium valproate, Clostridium difficile-associated diarrhea, Development of drug-resistant bacteria, Pneumonitis with inhalational use, Other common side effects may include; headache, diarrhea, nausea, vaginal ,itching or discharge, mild rash; or pain, swelling, or redness where the medicine was injected. Contraindications Doripenem is contraindicated in patients with known serious hypersensitivity to Doripenem or to other drugs in the same class or in patients who have demonstrated anaphylactic reactions to beta-lactams. Drug Interactions Interaction with Valproic Acid Due to a drug interaction, patients with seizure disorders controlled with valproic acid or sodium valproate will be at an increased risk for breakthrough seizures when treated with Doripenem concomitantly. Reduction in serum valproic acid concentrations to below the therapeutic concentration range (50 to 100 mcg/mL) was observed by 12 hours after the initiation of doripenem in healthy subjects co-administered both drugs. A similar drug interaction involving other carbapenem antibacterials and valproic acid has been described in published case reports. In some of these reports, increasing the dose of valproic acid or sodium valproate did not result in increased valproic acid serum concentrations. Alternative antibacterial therapies should be considered for patients receiving valproic acid or sodium valproate. If administration of Doripenem is necessary, supplemental anti-convulsant therapy should be considered. Precautions Serious and occasionally fatal hypersensitivity (anaphylactic) and serious skin reactions have been reported in patients receiving beta-lactam antibiotics. These reactions are more likely to occur in individuals with a history of sensitivity to multiple allergens. Before therapy with Doripenem is instituted, careful inquiry should be made to determine whether the patient has had a previous hypersensitivity reaction to other carbapenems, cephalosporins, penicillins or other allergens. If this product is to be given to a penicillin- or other beta-lactam-allergic patient, caution should be exercised because cross-hyperreactivity among beta-lactam antibiotics has been clearly documented. Pharmaceutical Precautions Storage of doripenem vials: doripenem should be stored at 25°C (77°F); excursions permitted to 15°–30°C (59° to 86°F). Keep out of the reach of children. Commercial Pack DorijectTM 500: Each commercial box contains one vial containing 500 mg of doripenem anhydrous sterile crystalline powder for intravenous infusion Delkof Antitussive PRESENTATION Delkof syrup: Bottle containing 100 ml syrup, Each 5 ml syrup contains Dextromethorphan hydrobromide BP 10 mg, Pseudophedrine hydrochloride BP 30 mg and Triprolidine hydrochloride BP 1.25 mg. DESCRIPTION Delkof syrup is a preparation of an antitussive decongestant and antihistamine. It is a combination of dextromethorphan, pseudoephedrine, and triprolidine. Dextromethorphan is a cough suppressant, which has a central action on the cough centre in the medulla. Pseudoephedrine is an effective upper respiratory decongestant, which produces its decongestant effect within 30 minutes and its effects lasts for at least 4 hours. Triprolidine provides symptomatic relief of allergic rhinitis and common cold. INDICATIONS Delkof is indicated for the symptomatic relief of unproductive cough in the following conditions: Allergic rhinitis Upper respiratory tract disorders DOSAGE AND ADMINISTRATION Adults and children over 12 years: 2 teaspoonful three times a day Children: 6-12 years: 1 teaspoonful three times a day 2-5 years: 1/2 teaspoonful three times a day or as recommended by the physician. SIDE-EFFECTS Side effects of dextromethorphan are rare and may include dizziness, gastro-intestinal disturbances. Pseudoephedrine may cause sympathetic hyperactivity such as fear, anxiety, restlessness, tremor, insomnia, confusion and irritability. Triprolidine may cause sedation. CONTRAINDICATIONS Delkof is contraindicated in patients with known hypersensitivity to any of its ingredients. It is contraindicated in patients with severe hypertension and severe coronary artery disease. Also contraindicated in person who are taking or have taken monoamine oxidase inhibitors within the preceding two weeks. DRUG INTERACTIONS Concomitant use Delkof with other sympathomimetic agents such as decongestants, tricyclic antidepressant, appetite suppressant and amphetamine- like psychostimulant or with monoamine oxidase inhibitors, which interfere with the catabolism of sympathomimetic amines, can occasionally raise the blood pressure. Pseudophedrine in Delkof may partially reverse the hypertensive action of drugs, which interfere with sympathetic activity including methyldopa, alpha-and beta-adrenergic blocking agents. PRECAUTIONS Delkof should be used with caution in patients taking hypertensive, tricyclic antidepressant or other sympathomimetic agents. Caution should be taken in severe hepatic and renal impairment. It should not be used for persistent cough due to smoking, asthma or emphysema or where cough is accompanied by excessive secretions unless recommended by a physician. PHARMACEUTICAL PRECAUTION Store in a cool (below 30°c), dry place, away from light. Keep out of reach of children. COMMERCIAL PACK Delkof syrup: Bottle containing 100 ml syrup.