Novamox Capsules (Generic Amoxicillin Trihydrate Capsules)

1. Novamox Capsules (Generic Amoxicillin Trihydrate Capsules) © The Swiss Pharmacy

2. Novamox Capsules (Generic Amoxicillin Trihydrate Capsules) Novamox (Generic Amoxicillin Trihydrate Capsules) is used to treat infections caused by bacteria in different parts of the body. Amoxicillin capsules may also be used in combination with other medicines to treat stomach ulcers. Novamox capsules are also indicated for the prophylaxis of endocarditis. © The Swiss Pharmacy

3. Novamox Capsules (Generic Amoxicillin Trihydrate Capsules) Novamox Capsules are manufactured by Cipla Limited, India in the strengths of 250 mg and 500 mg. © The Swiss Pharmacy

4. Novamox Capsules (Generic Amoxicillin Trihydrate Capsules) Chemical Structure © The Swiss Pharmacy

5. Novamox Capsules (Generic Amoxicillin Trihydrate Capsules) The active pharmaceutical ingredient contained in Novamox Capsules is Amoxicillin Trihydrate (Amoxycillin Trihydrate). Each hard gelatin capsule contains Amoxycillin Trihydrate IP equivalent to 250 mg or 500 mg of Amoxycillin ( Amoxicillin). © The Swiss Pharmacy

6. Novamox Capsules (Generic Amoxicillin Trihydrate Capsules) Uses of Novamox 250 mg and 500 mg Capsules: Novamox Capsules (Amoxicillin Trihydrate Capsules) is used to treat bacterial infections in many different parts of the body. It is also used with other medicines (e.g., Clarithromycin, Lansoprazole) to treat H. pylori infection and duodenal ulcers. Amoxicillin belongs to the group of medicines known as penicillin antibiotics. It works by killing the bacteria and preventing their growth. However, this medicine will not work for colds, flu, or other virus infections. Treatment of Infection: Amoxicillin is indicated in the treatment of infections due to susceptible organisms. Amoxicillin may be useful in instituting therapy prior to bacteriology; however bacteriological studies to determine the causative organisms and their sensitivity to Amoxicillin should be performed. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9484_Amoxicillin-Capsules.html https://www.theswisspharmacy.com/product_info.php?info=p9484_Amoxicillin-Capsules.html © The Swiss Pharmacy

7. Novamox Capsules (Generic Amoxicillin Trihydrate Capsules) Uses of Novamox 250 mg and 500 mg Capsules: Skin and Skin Structure: Staphylococcus, non-penicillinase producing; Streptococcus; E. coli. Respiratory (Acute and Chronic): H. influenzae; Streptococcus; S. pneumoniae; staphylococcus, non-penicillinase producing; E. coli. Genitourinary Tract (complicated and uncomplicated, Acute and Chronic): P.mirabilis;S. faecalis;E. coli Gonorrhoea, Acute, Uncomplicated (Ano-Genital and Urethral Infections) due to N. gonorrhoeae (males and females). URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9484_Amoxicillin-Capsules.html https://www.theswisspharmacy.com/product_info.php?info=p9484_Amoxicillin-Capsules.html © The Swiss Pharmacy

8. Novamox Capsules (Generic Amoxicillin Trihydrate Capsules) Uses of Novamox 250 mg and 500 mg Capsules: Prophylaxis of bacterial Endocarditis: Amoxicillin may be used for the prophylaxis of bacterial endocarditis associated with procedures such as dental extraction, in individuals at particular risk, such as those with a prosthetic heart valve or those who have previously had endocarditis. Amoxicillin capsules, in combination with Clarithromycin plus Lansoprazole as triple therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) to eradicate H. pylori. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9484_Amoxicillin-Capsules.html https://www.theswisspharmacy.com/product_info.php?info=p9484_Amoxicillin-Capsules.html © The Swiss Pharmacy

9. Novamox Capsules (Generic Amoxicillin Trihydrate Capsules) Recommended Adult Dosage The dose of Novamox Capsules Novamox Capsules (Generic Amoxycillin Trihydrate Capsules) for: Mild to Moderate intensity infection of Ear / Nose / Throat is 500 mg every 12 hours or 250 mg every 8 hours. In case of a Severe intensity infection of Ear/Nose/Throat it is 875 mg every 12 hours or 500 mg every 8 hours. Mild, Moderate or Severe intensity infection of Lower Respiratory Tract: It is 875 mg every 12 hours or 500 mg every 8 hours. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9484_Amoxicillin-Capsules.html https://www.theswisspharmacy.com/product_info.php?info=p9484_Amoxicillin-Capsules.html © The Swiss Pharmacy

10. Novamox Capsules (Generic Amoxicillin Trihydrate Capsules) Recommended Adult Dosage Mild to Moderate intensity infection of Skin or Skin Structure is 500 mg every 12 hours or 250 mg every 8 hours. In the case of a Severe intensity Skin or Skin Structure infection it is 875 mg every 12 hours or 500 mg every 8 hours Mild to Moderate intensity infection of Genitourinary Tract it is 500 mg every 12 hours or 250 mg every 8 hours In the case of a Severe intensity Genitourinary Tract infection 875 mg every 12 hours or 500 mg every 8 hours For Gonorrhea Acute,uncomplicated, ano-genital and urethral infections in males and females 3 grams as single oral dose. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9484_Amoxicillin-Capsules.html https://www.theswisspharmacy.com/product_info.php?info=p9484_Amoxicillin-Capsules.html © The Swiss Pharmacy

11. Novamox Capsules (Generic Amoxicillin Trihydrate Capsules) Contraindications ➔Novamox is contraindicated in patients with a known hypersensitivity (e.g., anaphylaxis or Stevens-Johnson syndrome) to Amoxycillin Trihydrate, to other beta-lactams (e.g., penicillins or cephalosporins) or any component of the capsule. ➔Novamox (Amoxicillin) is also contraindicated in cases where infectious mononucleosis is either suspected or confirmed. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9484_Amoxicillin-Capsules.html https://www.theswisspharmacy.com/product_info.php?info=p9484_Amoxicillin-Capsules.html © The Swiss Pharmacy

12. Novamox Capsules (Generic Amoxicillin Trihydrate Capsules) Storage Instructions Novamox Capsules (Generic Amoxicillin Trihydrate Capsules) have to be stored at controlled room temperature i.e. from 20°C to 25°C (68°F to 77°F) with excursions permitted between 15° to 30°C (59° to 86°F). Keep this as well as all other medicines away from children and pets. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9484_Amoxicillin-Capsules.html https://www.theswisspharmacy.com/product_info.php?info=p9484_Amoxicillin-Capsules.html © The Swiss Pharmacy

13. Novamox Capsules (Generic Amoxicillin Trihydrate Capsules) Warnings Anaphylactic reactions: Serious and occasionally fatal anaphylactic reactions have been reported in patients on penicillin therapy. Serious anaphylactic reactions require immediate emergency treatment with supportive measures. Clostridium difficile-associated diarrhea (ranging from mild diarrhea to fatal colitis): Evaluate if diarrhea occurs. The possibility of superinfections with mycotic or bacterial pathogens should be kept in mind during therapy. If superinfections occur, Amoxycillin should be discontinued and appropriate therapy instituted. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9484_Amoxicillin-Capsules.html https://www.theswisspharmacy.com/product_info.php?info=p9484_Amoxicillin-Capsules.html © The Swiss Pharmacy

14. Novamox Capsules (Generic Amoxicillin Trihydrate Capsules) Warnings Convulsions may occur in patients with impaired renal function or in those receiving high doses or in patients with predisposing factors (e.g. history of seizures, treated epilepsy or meningeal disorders. The occurrence at the treatment initiation of a feverish generalised erythema associated with pustula may be a symptom of acute generalised exanthemous pustulosis. This reaction requires Amoxicillin (Novamox capsules) discontinuation and contra-indicates any subsequent administration. The Jarisch-Herxheimer reaction has been seen following Amoxicillin treatment of Lyme disease. It results directly from the bactericidal activity of Amoxicillin on the causative bacteria of Lyme disease, the spirochaete Borrelia burgdorferi. Patients should be reassured that this is a common and usually self- limiting consequence of antibiotic treatment of Lyme disease. © The Swiss Pharmacy

15. Novamox Capsules (Generic Amoxicillin Trihydrate Capsules) Possible Side Effects Most common side effects with an incidence rate of greater than or equal to 1% observed in clinical trials of Amoxycillin Trihydrate capsules (Novamox), tablets or oral suspension were diarrhea, rash, vomiting, and nausea. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9484_Amoxicillin-Capsules.html https://www.theswisspharmacy.com/product_info.php?info=p9484_Amoxicillin-Capsules.html © The Swiss Pharmacy

16. Novamox Capsules (Generic Amoxicillin Trihydrate Capsules) Possible Side Effects In addition to side effects reported from clinical trials, the following events have been identified during postmarketing use of penicillins. Infections and Infestations: Mucocutaneous candidiasis. Gastrointestinal: Black hairy tongue, and hemorrhagic/pseudomembranous colitis. Onset of pseudomembranous colitis symptoms may occur during or after antibacterial treatment. Hypersensitivity Reactions: Anaphylaxis. Serum sickness–like reactions, erythematous maculopapular rashes, erythema multiforme, Stevens-Johnson syndrome, exfoliative dermatitis, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, hypersensitivity vasculitis, and urticaria have been reported. Liver: A moderate rise in AST and/or ALT has been noted, but the significance of this finding is unknown. Hepatic dysfunction including cholestatic jaundice, hepatic cholestasis and acute cytolytic hepatitis have been reported. Renal: Crystalluria has been reported. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9484_Amoxicillin-Capsules.html https://www.theswisspharmacy.com/product_info.php?info=p9484_Amoxicillin-Capsules.html © The Swiss Pharmacy

17. Novamox Capsules (Generic Amoxicillin Trihydrate Capsules) Possible Side Effects Hemic and Lymphatic Systems: Anemia, including hemolytic anemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, leukopenia, and agranulocytosis have been reported. These reactions are usually reversible on discontinuation of therapy and are believed to be hypersensitivity phenomena. Liver: A moderate rise in AST and/or ALT has been noted, but the significance of this finding is unknown. Hepatic dysfunction including cholestatic jaundice, hepatic cholestasis and acute cytolytic hepatitis have been reported. Renal: Crystalluria has been reported. Renal: Crystalluria has been reported. Hemic and Lymphatic Systems: Anemia, including hemolytic anemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, leukopenia, and agranulocytosis have been reported. These reactions are usually reversible on discontinuation of therapy and are believed to be hypersensitivity phenomena. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9484_Amoxicillin-Capsules.html https://www.theswisspharmacy.com/product_info.php?info=p9484_Amoxicillin-Capsules.html © The Swiss Pharmacy

18. Novamox Capsules (Generic Amoxicillin Trihydrate Capsules) Possible Side Effects Central Nervous System: Reversible hyperactivity, agitation, anxiety, insomnia, confusion, convulsions, behavioral changes, and/or dizziness have been reported. Miscellaneous: Tooth discoloration (brown, yellow, or gray staining) has been reported. Most reports occurred in pediatric patients. Discoloration was reduced or eliminated with brushing or dental cleaning in most cases. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9484_Amoxicillin-Capsules.html https://www.theswisspharmacy.com/product_info.php?info=p9484_Amoxicillin-Capsules.html © The Swiss Pharmacy

19. Novamox Capsules (Generic Amoxicillin Trihydrate Capsules) Overdosage In case of overdosage, discontinue Novamox (Generic Amoxycillin Trihydrate Capsules), treat symptomatically, and institute supportive measures as required. A prospective study of 51 pediatric patients at a poison-control center suggested that overdosages of less than 250 mg/kg of Amoxicillin are not associated with significant clinical symptoms. Interstitial nephritis resulting in oliguric renal failure has been reported in a small number of patients after overdosage with Amoxicillin (Novamox capsules). URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9484_Amoxicillin-Capsules.html https://www.theswisspharmacy.com/product_info.php?info=p9484_Amoxicillin-Capsules.html © The Swiss Pharmacy

20. Novamox Capsules (Generic Amoxicillin Trihydrate Capsules) Overdosage Crystalluria, in some cases leading to renal failure, has also been reported after Amoxicillin overdosage in adult and pediatric patients. In case of overdosage, adequate fluid intake and diuresis should be maintained to reduce the risk of Amoxicillin crystalluria. Renal impairment appears to be reversible with cessation of drug administration. High blood levels may occur more readily in patients with impaired renal function because of decreased renal clearance of Amoxicillin. Amoxicillin may be removed from circulation by hemodialysis. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9484_Amoxicillin-Capsules.html https://www.theswisspharmacy.com/product_info.php?info=p9484_Amoxicillin-Capsules.html © The Swiss Pharmacy

21. Novamox Capsules (Generic Amoxicillin Trihydrate Capsules) Novamox Capsules During Pregnancy Amoxicillin Trihydrate (Novamox capsules) has been classified by the US FDA as Pregnancy Category B. Reproduction studies have been performed in mice and rats at doses up to 2000 mg/kg (3 and 6 times the 3 g human dose, based on body surface area). There was no evidence of harm to the fetus due to Amoxicillin. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, Novamox (Amoxicillin capsules) should be used during pregnancy only if clearly needed. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9484_Amoxicillin-Capsules.html https://www.theswisspharmacy.com/product_info.php?info=p9484_Amoxicillin-Capsules.html © The Swiss Pharmacy

22. Novamox Capsules (Generic Amoxicillin Trihydrate Capsules) Novamox Capsules Novamox Capsules (Generic Amoxicillin Trihydrate Capsules) are manufactured by Cipla Limited, India. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9484_Amoxicillin-Capsules.html https://www.theswisspharmacy.com/product_info.php?info=p9484_Amoxicillin-Capsules.html © The Swiss Pharmacy